Pointe Scientific, Inc.,
Medical device manufacturer in Canton, MI.
74510(k) clearances
0PMA approvals
50recalls
Device types
- CFR Hexokinase, Glucose 4
- CIG Diazo Colorimetry, Bilirubin 4
- JFJ Catalytic Methods, Amylase 4
- LCP Assay, Glycosylated Hemoglobin 4
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 3
- LBR Ldl & Vldl Precipitation, Hdl 3
- CIC Cresolphthalein Complexone, Calcium 3
- KHS Enzymatic, Carbon-Dioxide 3
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 3
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2
- JIY Photometric Method, Iron (Non-Heme) 2
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 2
- CIJ Saccharogenic, Amylase 2
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 2
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 2
- KNK Acid, Uric, Uricase (Colorimetric) 2
- CDQ Urease And Glutamic Dehydrogenase, Urea… 2
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 2
- CGA Glucose Oxidase, Glucose 2
- JGP Lowry (Colorimetric), Total Protein 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | 12/04/2007SE |
| K062118 | Pointe 360CFR · Traditional | 07/13/2007SE |
| K070251 | Carbon Dioxide Liquid Stable ReagentKHS · Traditional | 04/30/2007SE |
| K070207 | Multi-Analyte Chemistry CalibratorJIX · Abbreviated | 04/13/2007SE |
| K070504 | Ammonia/Alcohol Control SetJJY · Abbreviated | 04/11/2007SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | 03/28/2007SE |
| K051646 | Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and HighJGS · Traditional | 10/07/2005SE |
| K040391 | Total Bilirubin Reagent SetCIG · Traditional | 06/02/2004SE |
| K031539 | Hemoglobin A1C Reagent SetLCP · Traditional | 08/06/2003SE |
| K023860 | Microalbumin Reagent Set and CalibratorsDDZ · Traditional | 04/28/2003SE |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DehydrogenaseJBF · Traditional | 03/31/2003SE |
| K023396 | Amylase EPS-G7 (Liquid) Reagent Set, (Hitachi Analyzers)CIJ · Traditional | 12/23/2002SE |
| K002199 | Modification to Liquid Glucose (Hexokinase) Reagent SetCFR · Traditional | 11/20/2000SE |
| K002651 | C-Reactive Protein (High Sensitivity) Reagent SetDCK · Traditional | 10/13/2000SE |
| K993590 | Fructosamine Reagent Set, Calibrator, and Control SetLCP · Traditional | 12/21/1999SE |
| K992002 | Autohdl Cholesterol Reagent SetLBR · Traditional | 08/05/1999SE |
| K981978 | Autoldl Cholesterol Reagent Set and Autoldl Cholesterol CalibratorMRR · Traditional | 07/22/1998SE |
| K973588 | Liquid Alkaline Phoshatase Reagent SetCJE · Traditional | 10/22/1997SE |
| K973157 | Liquid GGT (Gamma Glutamyl Transferase) Reagent SetJQB · Traditional | 10/10/1997SE |
| K973589 | Liquid Ldh-L Reagent SetCFJ · Traditional | 10/08/1997SE |
| K972725 | Alcohol Reagent SetDIC · Traditional | 09/25/1997SE |
| K971754 | Liquid Glucose (Hexokinase) Reagent SetCFR · Traditional | 07/22/1997SE |
| K972671 | Bun (Liquid) Reagent SetCDQ · Traditional | 07/20/1997SE |
| K970933 | Auto HDL Cholesterol CalibratorJIS · Traditional | 05/23/1997SE |
| K970781 | Liquid Glucose (Oxidase) Reagent SetCGA · Traditional | 04/21/1997SE |
| K970560 | Uric Acid (Liquid) Reagent SetKNK · Traditional | 03/11/1997SE |
| K961588 | Total Iron (Nitro-Paps) Reagent SetJIY · Traditional | 11/18/1996SE |
| K961431 | Lactate Dehydrogenase Reagent SetCFJ · Traditional | 06/03/1996SE |
| K940735 | Liquid Amylase (CNPG3) Reagent SetCIJ · Traditional | 08/01/1994SE |
| K941287 | Liquid Alt(Sgpt) Reagent SetCKA · Traditional | 05/03/1994SE |
| K941132 | Liquid Ast (Sgot)Reagent SetCIT · Traditional | 05/02/1994SE |
| K935463 | Creatine Kinase-Mb (Ck-Mb) Reagent SetCGS · Traditional | 01/11/1994SE |
| K930475 | Liquid Amylase Reagent SetJFJ · Traditional | 07/19/1993SE |
| K930660 | Creatine Kinase (CK) Reagent SetCGS · Traditional | 03/29/1993SE |
| K920449 | Pointe 750 GlycometerLCP · Traditional | 07/28/1992SE |
| K921625 | Calcium-Arsenazo III Reagent SetCIC · Traditional | 05/13/1992SE |
| K914873 | Diazo Colorimetry, BilirubinCIG · Traditional | 12/04/1991SE |
| K910158 | AmylaseJFJ · Traditional | 04/30/1991SE |
| K896812 | Carbon Dioxide ReagentKHS · Traditional | 02/23/1990SE |
| K896590 | Carbon Dioxide ReagentKHS · Traditional | 02/01/1990SE |
| K891117 | HDL Cholesterol ReagentLBR · Traditional | 04/10/1989SE |
| K874131 | Cresolphthalein Complexone, CalciumCIC · Traditional | 12/04/1987SE |
| K864882 | Ferrozine (Colorimetric) Iron Binding CapacityJIY · Traditional | 01/21/1987SE |
| K864464 | Psi Amylase ReagentJFJ · Traditional | 01/21/1987SE |
| K863832 | Naphthyl Phosphate, Acid PhosphataseJFH · Traditional | 12/16/1986SE |
| K862033 | TriglyceridesCDT · Traditional | 07/22/1986SE |
| K860572 | Glycohemoglobin, In-Vitro Diagnostic Reagent SetLCP · Traditional | 05/16/1986SE |
| K860257 | Direct BilirubinCIG · Traditional | 02/21/1986SE |
| K853592 | MagnesiumJGJ · Traditional | 09/16/1985SE |
| K852169 | Chloride ReagentCHJ · Traditional | 08/21/1985SE |
| K851432 | HemoglobinKHG · Traditional | 07/12/1985SE |
| K832889 | AmylaseJFJ · Traditional | 11/25/1983SE |
| K832872 | Hexokinase, GlucoseCFR · Traditional | 10/14/1983SE |
| K832871 | Lipase Hydrolysis/Glycerol KinaseCDT · Traditional | 10/14/1983SE |
| K832870 | Diazo Colorimetry, BillirubinCIG · Traditional | 09/26/1983SE |
| K830556 | CreatinineCGX · Traditional | 03/24/1983SE |
| K822471 | Psi Albumin ReagentCIX · Traditional | 09/14/1982SE |
| K822470 | Psi Inorganic PhosphorusCEO · Traditional | 09/14/1982SE |
| K822469 | Psi Calcium ReagentCIC · Traditional | 09/14/1982SE |
| K822468 | Psi Total Protein ReagentCEK · Traditional | 09/14/1982SE |
| K813496 | Ldh-LCFJ · Traditional | 12/31/1981SE |
| K813495 | Alt (SGPT)CKA · Traditional | 12/31/1981SE |
| K813406 | Cpk(Ck) in Vitro Diag. Reagent SetJHS · Traditional | 12/22/1981SE |
| K813405 | Ast(Sgot) in Vitro Diag. Reagent SetCIT · Traditional | 12/22/1981SE |
| K812794 | LipaseCET · Traditional | 10/20/1981SE |
| K812699 | AmylaseKHM · Traditional | 10/06/1981SE |
| K812574 | HDL Cholesterol ReagentLBR · Traditional | 09/24/1981SE |
| K812452 | Alkaline PhosphataseCJE · Traditional | 09/09/1981SE |
| K812430 | Uric Acid Reagent SetKNK · Traditional | 09/09/1981SE |
| K812341 | Urea Nitrogen (Bun)CDQ · Traditional | 09/01/1981SE |
| K812296 | Gamma Glutamy TranspeptidaseJQB · Traditional | 08/31/1981SE |
| K810680 | Enzymatic TriglycerideCDT · Traditional | 03/31/1981SE |
| K810674 | Glucose OxidaseCGA · Traditional | 03/31/1981SE |
| K810673 | Enzymatic CholesterolCHH · Traditional | 03/31/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2487-2015 Class II | Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1…A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of… | 05/19/2015Terminated |
| Z-2764-2015 Class III | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE…Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during… | 03/13/2015Terminated |
| Z-2773-2015 Class III | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic…Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and… | 12/12/2014Terminated |
| Z-1036-2010 | Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog…An additional 10% picric acid was added to the R2 component during production. | 12/01/2009Terminated |
| Z-1035-2010 | Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog #…An additional 10% picric acid was added to the R2 component during production. | 12/01/2009Terminated |
| Z-0913-2010 | Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton…A process deviation occurred during the production of the R1 component which may affect its performance. | 12/01/2009Terminated |
| Z-0912-2010 | Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI…A process deviation occurred during the production of the R1 component which may affect its performance. | 12/01/2009Terminated |
| Z-0906-2010 | Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0905-2010 | Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI.…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0904-2010 | Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI.…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0903-2010 | Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0902-2010 | Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0901-2010 | Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0900-2010 | Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0899-2010 | Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-1043-2010 | Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set…Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this… | 11/10/2009Terminated |
| Z-1042-2010 | Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set…Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this… | 11/10/2009Terminated |
| Z-1041-2010 | Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe…Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this… | 11/10/2009Terminated |
| Z-0860-2010 | Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog #…The firm initiated the recall due to the presence of visible contamination of the product. | 11/10/2009Terminated |
| Z-0859-2010 | Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set…The firm initiated the recall due to the presence of visible contamination of the product. | 11/10/2009Terminated |
| Z-0104-2010 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI…There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL. | 10/19/2009Terminated |
| Z-1014-2010 | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI.…R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and… | 07/29/2009Terminated |
| Z-1202-2009 | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The…The product performance fails due to precipitation of the R2 component. | 02/02/2009Terminated |
| Z-1201-2009 | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc.…The R1 reagent has microbial contamination. | 01/29/2009Terminated |
| Z-1200-2009 | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc.…The R1 reagent has microbial contamination. | 01/29/2009Terminated |
| Z-1091-2009 | Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set…The product is unable to maintain the specification for linearity through the shelf life of the product. | 11/03/2008Terminated |
| Z-0224-2009 | Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0223-2009 | Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0222-2009 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0221-2009 | Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0220-2009 | Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0219-2009 | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0172-2009 | AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no.…The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure… | 08/25/2008Terminated |
| Z-0171-2009 | Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in…The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure… | 08/25/2008Terminated |
| Z-1360-2008 | Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1359-2008 | Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos.…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1358-2008 | Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos.…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1357-2008 | Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1356-2008 | Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1355-2008 | Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1354-2008 | Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1353-2008 | Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625…May be contaminated with microorganisms. | 02/07/2008Terminated |
| Z-1117-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1116-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1115-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1114-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1113-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1112-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1111-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |
| Z-1110-2008 | Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of…Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. | 12/14/2007Terminated |