Cleared Traditional

K903123 - RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT

K903123 is an FDA 510(k) clearance for RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT, manufactured by Reagents Applications, Inc.. The device is a Class 1 Chemistry device with product code JIQ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K903123 · Reagents Applications, Inc. · Chemistry device
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Sep 1990
Decision
60d
Days
Class 1
Risk

K903123 is an FDA 510(k) clearance for the RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on September 14, 1990 after a review of 60 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 Reagents Applications, Inc. devices

FDA 510(k) Submission Details - K903123

510(k) Number K903123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1990
Decision Date September 14, 1990
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

JIQ Device Classification - Class 1, General Controls

Product Code JIQ Turbidimetric 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 - JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

All 11
Devices cleared under the same product code (JIQ) and FDA review panel - the closest regulatory comparables to K903123.
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