Product Code: JIN FDA class 1 21 CFR 862.1435

Nitroprusside, Ketones (Urinary, Non-Quant.)

Clinical Chemistry

Nitroprusside for Ketones (Urinary, Non-Quantitative) is a clinical chemistry test system that uses the sodium nitroprusside reaction to detect the presence of ketone bodies in urine on a non-quantitative basis, used for screening in diabetic ketoacidosis and other ketotic states. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JIN, regulated under 21 CFR 862.1435, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

102

Registration Numbers

102

Unique Applicants

Years Active

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Basic Information

Product Code: JIN
Device Class: FDA class 1
Regulation Number: 862.1435
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201551	KetoSens BT Blood B-Ketone Monitoring System	Sep 09, 2020	Substantially Equivalent	I-Sens, Inc.
K192957	VivaChek Blood Glucose and B-Ketone Monitoring System	Jun 05, 2020	Substantially Equivalent	Vivachek Biotech (Hangzhou) Co., Ltd.
K182593	KET-1 Blood Ketone Monitoring System	Dec 18, 2018	Substantially Equivalent	Apex BioTechnology Corp.
K173345	TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System	May 04, 2018	Substantially Equivalent	Taidoc Technology Corporation
K170463	KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System	Apr 13, 2018	Substantially Equivalent	I-Sens, Inc.
K170587	On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis	Jul 06, 2017	Substantially Equivalent	ACON Laboratories, Inc.
K060768	PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS	Apr 21, 2006	Substantially Equivalent	Abbott Diabetes Care, Inc.
K033114	KETOCHECKS	Apr 26, 2004	Substantially Equivalent	Neo Diagnostics, Inc.
K003987	URS-1K (KETONE TESST)	Apr 26, 2001	Substantially Equivalent	Teco Diagnostics
K953662	FIRST CHOICE KETONES URINE TEST STRIPS	Jun 14, 1996	Substantially Equivalent	Polymer Technology Intl.
K953680	FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS	Jun 12, 1996	Substantially Equivalent	Polymer Technology Intl.
K912373	KETO-340 II	Jul 01, 1991	Substantially Equivalent	Ihara Medics U.S., Inc.
K911801	KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON	Jul 01, 1991	Substantially Equivalent	Gds Technology, LLC
K910108	GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED	Mar 04, 1991	Substantially Equivalent	Gds Diagnostics
K903365	KETOREX SANWA STANDARDS	Dec 20, 1990	Substantially Equivalent	Ihara Medics U.S., Inc.
K903367	KETONE TEST A SANWA STANDARD	Nov 20, 1990	Substantially Equivalent	Ihara Medics U.S., Inc.
K903366	KETONE TEST B SANWA STANDARD	Nov 20, 1990	Substantially Equivalent	Ihara Medics U.S., Inc.
K875029	ABBOTT BREATH ACETONE ANALYZER	May 27, 1988	Substantially Equivalent	Abbott Laboratories
K850368	SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV	Aug 30, 1985	Substantially Equivalent	Sigma Chemical Co.
K841715	KYOTEST UK URINE TEST REAGENT STRIP	May 31, 1984	Substantially Equivalent	Kyoto Diagnostics, Inc.
K831499	GLUCOSE 3, INLAB REAGENT STRIPS-URINALY	Jun 17, 1983	Substantially Equivalent	Laprol Scientific, Inc.
K830976	HELENA BIOSTRIP K	May 04, 1983	Substantially Equivalent	Helena Laboratories
K830975	PLAN A LIFE	May 04, 1983	Substantially Equivalent	New Directions Co.
K801270	TEST FOR KETONE IN URINE(ACETOACETIC AC	Jul 08, 1980	Substantially Equivalent	Miles Laboratories, Inc.