Cleared Traditional

DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI (K851338) - FDA 510(k) Clearance

Class I Chemistry device.

K851338 · Diagnostic Products Corp. · Chemistry device
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Apr 1986
Decision
369d
Days
Class 1
Risk

K851338 is an FDA 510(k) clearance for the DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Products Corp. devices

Submission Details

510(k) Number K851338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1985
Decision Date April 07, 1986
Days to Decision 369 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
281d slower than avg
Panel avg: 88d · This submission: 369d
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 37
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K851338.
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UALB
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CHEMSTRIP MICRAL URINE TEST STRIPS
K954346 · Boehringer Mannheim Corp. · Oct 1995
TINA-QUANT MICROALBUMIN
K932950 · Boehringer Mannheim Corp. · Feb 1995
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752 · Boehringer Mannheim Corp. · Apr 1991