Cleared Traditional

OLYMPUS ALBUMIN REAGENT (K922369) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922369 · Olympus Corp. · Chemistry device
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Jul 1992
Decision
58d
Days
Class 2
Risk

K922369 is an FDA 510(k) clearance for the OLYMPUS ALBUMIN REAGENT. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on July 17, 1992 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 Olympus Corp. devices

Submission Details

510(k) Number K922369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date July 17, 1992
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 33
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K922369.
EMDS ALBUMIN (ALB) TEST
K935179 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS ALBUMIN REAGENT
K924368 · Olympus Corp. · Feb 1993
ALBUMIN TEST
K923959 · Em Diagnostic Systems, Inc. · Dec 1992
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888 · Technicon Instruments Corp. · Nov 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920 · Em Diagnostic Systems, Inc. · Sep 1991
KODAK EKTACHEM DT SLIDES (ALB)
K913195 · Eastman Kodak Company · Aug 1991