Quantimetrix Corp.
Medical device manufacturer in Redondo Beach, CA.
39510(k) clearances
0PMA approvals
5recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 7
- JJX Single (Specified) Analyte Controls… 6
- DIF Drug Mixture Control Materials 5
- JJT Enzyme Controls (Assayed And Unassayed) 3
- JJW Urinalysis Controls (Assayed And Unassayed) 2
- JJR Electrolyte Controls (Assayed And Unassayed) 2
- CEK Biuret (Colorimetric), Total Protein 2
- JHO Electrophoretic Separation, Lipoproteins 2
- LAS Drug Specific Control Materials 1
- CJW Bromcresol Purple Dye-Binding, Albumin 1
- GGM Control, Hemoglobin 1
- DIJ Lead, Delta Amino Levulinic Acid 1
- DKB Calibrators, Drug Mixture 1
- JPK Mixture, Hematology Quality Control 1
- JIX Calibrator, Multi-Analyte Mixture 1
- JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine… 1
- LDP Colorimetry, Acetaminophen 1
- DKJ Colorimetry, Salicylate 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K152117 | Dropper hsCRP High Sensitivity CRP ControlJJX · Traditional | 04/21/2016SE |
| K142262 | Aution Check PlusJJW · Traditional | 04/10/2015SE |
| K113177 | Complete D 25-OH Vitamin D ControlJJX · Traditional | 05/10/2012SE |
| K103744 | Dropper A1C Diabetes ControlJJX · Traditional | 05/12/2011SE |
| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | 10/30/2006SE |
| K062751 | Modification to Quantimetrix Cardiasure Cardiac MarkerJJT · Special | 10/03/2006SE |
| K060417 | Modification to Quantimetrix Urine Drugs of Abuse ControlDIF · Special | 03/21/2006SE |
| K032791 | Glycohemosure HBA1C ControlGGM · Traditional | 10/30/2003SE |
| K030826 | Preciset Dat AmphetamineDIJ · Traditional | 04/03/2003SE |
| K021393 | Preciset Dat PlusDKB · Traditional | 06/13/2002SE |
| K013662 | Modification to Lipoprint System, LDL SubfractionsJHO · Special | 03/08/2002SE |
| K010337 | Lipoprint System, LDL SubfractionsJHO · Traditional | 07/25/2001SE |
| K010598 | Synovialscopics, Synovial Fluid ControlJPK · Traditional | 03/23/2001SE |
| K993723 | Cardiasure Cardiac Markers ControlJJT · Traditional | 11/23/1999SE |
| K973894 | ImmusureJJY · Traditional | 10/29/1997SE |
| K970862 | SpinalscopicsJJY · Traditional | 04/08/1997SE |
| K943394 | Prostat ControlJJY · Traditional | 05/23/1995SE |
| K943925 | Sweat Controls for Cystic Fibrosis TestingJJR · Traditional | 10/04/1994SE |
| K941130 | Assure Urine HCG ControlJJX · Traditional | 06/03/1994SE |
| K932623 | Quantimetrix Blood Glucose ControlsJIX · Traditional | 12/09/1993SE |
| K931523 | Quantimetrix C-Clear(Tm)JMA · Traditional | 06/25/1993SE |
| K925256 | Quantimetrix Urinalysis Microscopics ControlJJY · Traditional | 03/01/1993SE |
| K913346 | Quantimetrix Ammonia ControlsJJX · Traditional | 09/25/1991SE |
| K880701 | Quantimetrix Serum Enzyme ControlJJT · Traditional | 03/24/1988SE |
| K863388 | Quantimetrix Drug Free Serum ControlDIF · Traditional | 09/29/1986SE |
| K861420 | Quantimetrix Drug Free Human Urine ControlJJY · Traditional | 09/16/1986SE |
| K860942 | Quantimetrix Human Bilirubin Control I & II LiquidJJY · Traditional | 05/23/1986SE |
| K853932 | Quanttest Total Protein AssayCEK · Traditional | 12/19/1985SE |
| K853930 | Quantimetrix Biuret Serum Total Protein Assay KitCEK · Traditional | 12/10/1985SE |
| K853933 | Quantimetrix Human Serum Therapeutic Drug ControlDIF · Traditional | 10/04/1985SE |
| K853931 | Quantimetrix Human Serum Chemistry ControlJJY · Traditional | 10/04/1985SE |
| K843818 | Human Serum Anticonvulsant Drug ControlDIF · Traditional | 10/30/1984SE |
| K843679 | Human Serum Cardioactive Drug ControlDIF · Traditional | 10/05/1984SE |
| K834505 | Human Serum Electrolyte Control-LiquidJJR · Traditional | 04/13/1984SE |
| K832045 | Acetaminopher Assay KitLDP · Traditional | 10/04/1983SE |
| K831526 | Urine Total Protein ControlJJW · Traditional | 08/12/1983SE |
| K831527 | Spinal Fluid Total Protein ControlJJX · Traditional | 07/18/1983SE |
| K831336 | Salicylate Assay KitDKJ · Traditional | 07/07/1983SE |
| K830934 | Quantimetrix Bromeresol Purple AlbuminCJW · Traditional | 04/18/1983SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2257-2018 Class III | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus…The kits contained an incorrect lot of Dropper Plus Level 1 vials | 12/21/2017Terminated |
| Z-0516-2009 | Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |
| Z-0515-2009 | Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |
| Z-0514-2009 | Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |
| Z-0513-2009 | Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle…This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and… | 06/01/2007Terminated |