Cleared Traditional

K972337 - DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA

K972337 is an FDA 510(k) clearance for DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA, manufactured by Diagnostic Chemicals , Ltd.. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K972337 · Diagnostic Chemicals , Ltd. · Chemistry device
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Aug 1997
Decision
46d
Days
Class 1
Risk

K972337 is an FDA 510(k) clearance for the DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on August 8, 1997 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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.

View all Diagnostic Chemicals , Ltd. devices

FDA 510(k) Submission Details - K972337

510(k) Number K972337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1997
Decision Date August 08, 1997
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

JIR Device Classification - Class 1, General Controls

Product Code JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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 - JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)

All 30
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K972337.
UALB
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K963142 · Bayer Corp. · Sep 1996
TOTAL PROTEIN (URINE)
K951222 · Randox Laboratories, Ltd. · Apr 1996