Cleared Traditional

K904752 - CHEMSTRIP MICRAL(TM) URINE TEST STRIPS

K904752 is an FDA 510(k) clearance for CHEMSTRIP MICRAL(TM) 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 175-day FDA review.

K904752 · Boehringer Mannheim Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1991
Decision
175d
Days
Class 1
Risk

K904752 is an FDA 510(k) clearance for the CHEMSTRIP(R) MICRAL(TM) 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 April 12, 1991 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K904752

510(k) Number K904752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1990
Decision Date April 12, 1991
Days to Decision 175 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
87d slower than avg
Panel avg: 88d · This submission: 175d
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 K904752.
N-ASSAY TIA MICROALBUMIN
K934146 · Crestat Diagnostics, Inc. · Jan 1994
SYN ELISA MICRO ALBUMIN
K920216 · Elias U.S.A., Inc. · Mar 1992
TARGET MICROALBUMINURIA TEST
K912246 · Texas Immunology, Inc. · Jul 1991
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204 · Stanbio Laboratory · Aug 1990
BIOTEL MICROALBUMINURIA (TM)
K894169 · American Diagnostic Corp. · Sep 1989
BIOTROL URINE PROTEINS REAGENT
K890846 · Biotrol, USA, Inc. · Mar 1989