Cleared Traditional

K910108 - GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

K910108 is an FDA 510(k) clearance for GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT..., manufactured by Gds Diagnostics. The device is a Class 1 Chemistry device with product code JIN cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K910108 · Gds Diagnostics · Chemistry device
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Mar 1991
Decision
53d
Days
Class 1
Risk

K910108 is an FDA 510(k) clearance for the GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by Gds Diagnostics (Elkhart, US). The FDA issued a Cleared decision on March 4, 1991 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K910108

510(k) Number K910108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1991
Decision Date March 04, 1991
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 89d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

JIN Device Classification - Class 1, General Controls

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 23
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K910108.
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
K953680 · Polymer Technology Intl. · Jun 1996
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
K911801 · Gds Technology, LLC · Jul 1991
KETO-340 II
K912373 · Ihara Medics U.S., Inc. · Jul 1991
KETOREX SANWA STANDARDS
K903365 · Ihara Medics U.S., Inc. · Dec 1990
KETONE TEST B SANWA STANDARD
K903366 · Ihara Medics U.S., Inc. · Nov 1990
KETONE TEST A SANWA STANDARD
K903367 · Ihara Medics U.S., Inc. · Nov 1990
K910108 · GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
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