Cleared Traditional

K954346 - CHEMSTRIP MICRAL URINE TEST STRIPS

K954346 is an FDA 510(k) clearance for CHEMSTRIP MICRAL URINE TEST STRIPS, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K954346 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
38d
Days
Class 1
Risk

K954346 is an FDA 510(k) clearance for the CHEMSTRIP MICRAL URINE TEST STRIPS. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 38 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K954346

510(k) Number K954346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date October 26, 1995
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 28
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K954346.
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
K963142 · Bayer Corp. · Sep 1996
TOTAL PROTEIN (URINE)
K951222 · Randox Laboratories, Ltd. · Apr 1996
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
K955438 · Teco Diagnostics · Jan 1996
TINA-QUANT MICROALBUMIN
K932950 · Boehringer Mannheim Corp. · Feb 1995
N-ASSAY TIA MICROALBUMIN
K934146 · Crestat Diagnostics, Inc. · Jan 1994
SYN ELISA MICRO ALBUMIN
K920216 · Elias U.S.A., Inc. · Mar 1992