Cleared Traditional

STANBIO CSF/URINE TOTAL PROTEIN TEST SET (K902204) - FDA 510(k) Clearance

Class I Chemistry device.

K902204 · Stanbio Laboratory · Chemistry device
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Aug 1990
Decision
98d
Days
Class 1
Risk

K902204 is an FDA 510(k) clearance for the STANBIO CSF/URINE TOTAL PROTEIN TEST SET. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 98 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 Stanbio Laboratory devices

Submission Details

510(k) Number K902204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date August 22, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
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
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K904752 · Boehringer Mannheim Corp. · Apr 1991