Cleared Traditional

K922032 - ENZIP URINARY MICROALBUMIN TEST

K922032 is an FDA 510(k) clearance for ENZIP URINARY MICROALBUMIN TEST, manufactured by Diagnostic Specialties. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K922032 · Diagnostic Specialties · Chemistry device
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Jul 1992
Decision
90d
Days
Class 1
Risk

K922032 is an FDA 510(k) clearance for the ENZIP URINARY MICROALBUMIN TEST. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Diagnostic Specialties (Metuchen, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 90 days - within the typical 510(k) review window.

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 Diagnostic Specialties devices

FDA 510(k) Submission Details - K922032

510(k) Number K922032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date July 30, 1992
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
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 31
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K922032.
CHEMSTRIP MICRAL URINE TEST STRIPS
K954346 · Boehringer Mannheim Corp. · Oct 1995
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
TARGET MICROALBUMINURIA TEST
K912246 · Texas Immunology, Inc. · Jul 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752 · Boehringer Mannheim Corp. · Apr 1991