Nitroprusside, Ketones (Urinary, Non-Quant.)
FDA product code JIN · Class I (low risk) · 21 CFR 862.1435 · Clinical Chemistry
24510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Ihara Medics U.S., Inc. 4
- I-Sens, Inc. 2
- Polymer Technology Intl. 2
- Gds Technology, LLC 1
- Vivachek Biotech (Hangzhou) Co., Ltd. 1
- Apex BioTechnology Corp. 1
- Taidoc Technology Corporation 1
- ACON Laboratories, Inc. 1
- Abbott Diabetes Care, Inc. 1
- Neo Diagnostics, Inc. 1
- Teco Diagnostics 1
- Miles Laboratories, Inc. 1
- Gds Diagnostics 1
- Abbott Laboratories 1
- Sigma Chemical Co. 1
- Kyoto Diagnostics, Inc. 1
- Laprol Scientific, Inc. 1
- Helena Laboratories 1
- New Directions Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201551 | KetoSens BT Blood B-Ketone Monitoring SystemJIN · Special | I-Sens, Inc. | 09/09/2020SE |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/05/2020SE |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | Apex BioTechnology Corp. | 12/18/2018SE |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemJIN · Traditional | Taidoc Technology Corporation | 05/04/2018SE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional | I-Sens, Inc. | 04/13/2018SE |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for…JIN · Traditional | ACON Laboratories, Inc. | 07/06/2017SE |
| K060768 | Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsJIN · Special | Abbott Diabetes Care, Inc. | 04/21/2006SE |
| K033114 | KetochecksJIN · Traditional | Neo Diagnostics, Inc. | 04/26/2004SE |
| K003987 | URS-1K (Ketone Tesst)JIN · Traditional | Teco Diagnostics | 04/26/2001SE |
| K953662 | First Choice Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/14/1996SE |
| K953680 | First Choice Glucose & Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/12/1996SE |
| K912373 | KETO-340 IIJIN · Traditional | Ihara Medics U.S., Inc. | 07/01/1991SE |
| K911801 | Ketosite(Tm)/Stat-Site(Tm)/Ketosite(Tm) Low-Hi ConJIN · Traditional | Gds Technology, LLC | 07/01/1991SE |
| K910108 | GDS Enzymatic B-Hydroxybutyrate Reagent ModifiedJIN · Traditional | Gds Diagnostics | 03/04/1991SE |
| K903365 | Ketorex Sanwa StandardsJIN · Traditional | Ihara Medics U.S., Inc. | 12/20/1990SE |
| K903367 | Ketone Test a Sanwa StandardJIN · Traditional | Ihara Medics U.S., Inc. | 11/20/1990SE |
| K903366 | Ketone Test B Sanwa StandardJIN · Traditional | Ihara Medics U.S., Inc. | 11/20/1990SE |
| K875029 | Abbott Breath Acetone AnalyzerJIN · Traditional | Abbott Laboratories | 05/27/1988SE |
| K850368 | Sigms B-Hydroxybutarate Procedure No. 310-UVJIN · Traditional | Sigma Chemical Co. | 08/30/1985SE |
| K841715 | Kyotest UK Urine Test Reagent StripJIN · Traditional | Kyoto Diagnostics, Inc. | 05/31/1984SE |
| K831499 | Glucose 3, Inlab Reagent Strips-UrinalyJIN · Traditional | Laprol Scientific, Inc. | 06/17/1983SE |
| K830976 | Helena Biostrip KJIN · Traditional | Helena Laboratories | 05/04/1983SE |
| K830975 | Plan a LifeJIN · Traditional | New Directions Co. | 05/04/1983SE |
| K801270 | Test for Ketone in Urine(Acetoacetic AcJIN · Traditional | Miles Laboratories, Inc. | 07/08/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2087-2026 Class II | One Step K in vitro diagnostic test REF: 81A4The devices were distributed without required FDA premarket clearance or approval. | DFI Co., Ltd. | 04/02/2026Open, Classified |
| Z-1258-2026 Class II | The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis…Test strips and other tests including for near-patient testing, that require a 510(k) were distributed… | Changchun Wancheng Bio-Electron Co., Ltd. | 11/22/2025Open, Classified |
| Z-0490-2024 Class II | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro…Deterioration in the stability of the Test Strips results in diminished low-range detection capability and… | Stanbio Laboratory, LP | 10/02/2023Open, Classified |
| Z-0056-2024 Class II | PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREEUniversal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0046-2024 Class II | HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test stripsUniversal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… | Universal Meditech Inc. | 05/22/2023Open, Classified |
| Z-0932-2022 Class II | Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and…Product was improperly store which may cause a delay in results. | MEDLINE INDUSTRIES, LP - Northfield | 03/08/2022Terminated |
| Z-2203-2021 Class III | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro…Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | Stanbio Laboratory, LP | 07/12/2021Terminated |
| Z-2202-2021 Class III | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | Stanbio Laboratory, LP | 07/12/2021Terminated |
| Z-2201-2021 Class III | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | Stanbio Laboratory, LP | 07/12/2021Terminated |
| Z-2200-2021 Class III | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | Stanbio Laboratory, LP | 07/12/2021Terminated |
| Z-2199-2021 Class III | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.Deterioration in the stability of the reagents which has resulted in lower than expected or out of range… | Stanbio Laboratory, LP | 07/12/2021Terminated |
| Z-1407-2021 Class II | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site…Possible false negative or false positive results due to the product being compromised during shipment. | Medline Industries Inc | 03/15/2021Open, Classified |
| Z-2049-2020 Class II | B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for…Three products requiring refrigerated storage conditions were incorrectly stored outside of approved… | Cardinal Health Inc. | 04/20/2020Terminated |
| Z-1558-2020 Class II | FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters… | Abbott Diabetes Care, Inc. | 11/14/2019Terminated |