Cleared Traditional

K902216 - WAKO(TM) MICRO-ALBUMIN

K902216 is the FDA 510(k) clearance for WAKO(TM) MICRO-ALBUMIN by Wako Chemicals USA, Inc.. It is a Class 1 Chemistry device (product code JIQ) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K902216 · Wako Chemicals USA, Inc. · Chemistry device
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Jun 1990
Decision
33d
Days
Class 1
Risk

K902216 is an FDA 510(k) clearance for the WAKO(TM) MICRO-ALBUMIN. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on June 18, 1990 after a review of 33 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K902216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date June 18, 1990
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (JIQ) and FDA review panel - the closest regulatory comparables to K902216.
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
K944664 · Wako Chemicals USA, Inc. · Feb 1995
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RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
K903123 · Reagents Applications, Inc. · Sep 1990
BECKMAN MA MICROALBUMIN REAGENT KIT
K895883 · Beckman Instruments, Inc. · Dec 1989
ALBUMIN SCREEN TEST
K870516 · Sclavo, Inc. · Oct 1987
SULFOSALICYLIC ACID, 3% W/V
K842915 · E K Ind., Inc. · Aug 1984