JIN · Nitroprusside, Ketones (Urinary, Non-Quant.)
Clinical Chemistry · 21 CFR 862.1435 · Class 1
Overview
| Product Code | JIN |
|---|---|
| Device Name | Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Regulation | 21 CFR 862.1435 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | I-Sens, Inc. | Sep 9, 2020 | SESE |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | Jun 5, 2020 | SESE |
| K182593 | KET-1 Blood Ketone Monitoring System | Apex BioTechnology Corp. | Dec 18, 2018 | SESE |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | Taidoc Technology Corporation | May 4, 2018 | SESE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | I-Sens, Inc. | Apr 13, 2018 | SESE |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis | ACON Laboratories, Inc. | Jul 6, 2017 | SESE |
| K060768 | PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS | Abbott Diabetes Care, Inc. | Apr 21, 2006 | SESE |
| K033114 | KETOCHECKS | Neo Diagnostics, Inc. | Apr 26, 2004 | SESE |
| K003987 | URS-1K (KETONE TESST) | Teco Diagnostics | Apr 26, 2001 | SESE |
| K953662 | FIRST CHOICE KETONES URINE TEST STRIPS | Polymer Technology Intl. | Jun 14, 1996 | SESE |
| K953680 | FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS | Polymer Technology Intl. | Jun 12, 1996 | SESE |
| K912373 | KETO-340 II | Ihara Medics U.S., Inc. | Jul 1, 1991 | SESE |
| K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | Gds Technology, LLC | Jul 1, 1991 | SESE |
| K910108 | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED | Gds Diagnostics | Mar 4, 1991 | SESE |
| K903365 | KETOREX SANWA STANDARDS | Ihara Medics U.S., Inc. | Dec 20, 1990 | SESE |
| K903367 | KETONE TEST A SANWA STANDARD | Ihara Medics U.S., Inc. | Nov 20, 1990 | SESE |
| K903366 | KETONE TEST B SANWA STANDARD | Ihara Medics U.S., Inc. | Nov 20, 1990 | SESE |
| K875029 | ABBOTT BREATH ACETONE ANALYZER | Abbott Laboratories | May 27, 1988 | SESE |
| K850368 | SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV | Sigma Chemical Co. | Aug 30, 1985 | SESE |
| K841715 | KYOTEST UK URINE TEST REAGENT STRIP | Kyoto Diagnostics, Inc. | May 31, 1984 | SESE |
Top Applicants
- Ihara Medics U.S., Inc. — 4 clearances
- Polymer Technology Intl. — 2 clearances
- I-Sens, Inc. — 2 clearances
- Vivachek Biotech (Hangzhou) Co., Ltd. — 1 clearance
- Teco Diagnostics — 1 clearance
