Cleared Traditional

K963142 - DCA 2000 + MICROALBUMIN/CREATININE ASSAY

K963142 is an FDA 510(k) clearance for DCA 2000 + MICROALBUMIN/CREATININE ASSAY, manufactured by Bayer Corp.. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K963142 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
45d
Days
Class 1
Risk

K963142 is an FDA 510(k) clearance for the DCA 2000 + MICROALBUMIN/CREATININE ASSAY. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on September 27, 1996 after a review of 45 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 Bayer Corp. devices

FDA 510(k) Submission Details - K963142

510(k) Number K963142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1996
Decision Date September 27, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
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 K963142.
MICROALBUSTIX REAGENT STRIPS
K982219 · Bayer Corp. · Aug 1998
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA
K972337 · Diagnostic Chemicals , Ltd. · Aug 1997
ORGENTEC MICRO-ALBUMIN EIA ASSAY
K970932 · American Laboratory Products Co., Ltd. · Apr 1997
TOTAL PROTEIN (URINE)
K951222 · Randox Laboratories, Ltd. · Apr 1996
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
K960274 · Orgentec · Mar 1996
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
K955438 · Teco Diagnostics · Jan 1996