Cleared Traditional

K912246 - TARGET MICROALBUMINURIA TEST

K912246 is the FDA 510(k) clearance for TARGET MICROALBUMINURIA TEST by Texas Immunology, Inc.. It is a Class 1 Chemistry device (product code JIR) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K912246 · Texas Immunology, Inc. · Chemistry device
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Jul 1991
Decision
59d
Days
Class 1
Risk

K912246 is an FDA 510(k) clearance for the TARGET MICROALBUMINURIA TEST. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on July 19, 1991 after a review of 59 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 Texas Immunology, Inc. devices

Submission Details

510(k) Number K912246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date July 19, 1991
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 26
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K912246.
CHEMSTRIP MICRAL URINE TEST STRIPS
K954346 · Boehringer Mannheim Corp. · Oct 1995
TINA-QUANT MICROALBUMIN
K932950 · Boehringer Mannheim Corp. · Feb 1995
SYN ELISA MICRO ALBUMIN
K920216 · Elias U.S.A., Inc. · Mar 1992
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752 · Boehringer Mannheim Corp. · Apr 1991
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204 · Stanbio Laboratory · Aug 1990
BIOTEL MICROALBUMINURIA (TM)
K894169 · American Diagnostic Corp. · Sep 1989