Cleared Traditional

K902204 - STANBIO CSF/URINE TOTAL PROTEIN TEST SET

K902204 is an FDA 510(k) clearance for STANBIO CSF/URINE TOTAL PROTEIN TEST SET, manufactured by Stanbio Laboratory. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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.

FDA 510(k) Submission Details - K902204

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 89d · This submission: 98d
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 37
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K902204.
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K904752 · Boehringer Mannheim Corp. · Apr 1991
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
K896440 · Kenlor Industries, Inc. · Feb 1990
BIOTEL MICROALBUMINURIA (TM)
K894169 · American Diagnostic Corp. · Sep 1989
DIALBUMIN
K891544 · Exocell, Inc. · Jun 1989
K902204 · STANBIO CSF/URINE TOTAL PROTEIN TEST SET
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