Cleared Traditional

OLYMPUS ALBUMIN REAGENT (K924368) - FDA 510(k) Clearance

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

K924368 · Olympus Corp. · Chemistry device
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Feb 1993
Decision
164d
Days
Class 2
Risk

K924368 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 February 8, 1993 after a review of 164 days - an extended review 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: 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 Olympus Corp. devices

Submission Details

510(k) Number K924368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1992
Decision Date February 08, 1993
Days to Decision 164 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
76d slower than avg
Panel avg: 88d · This submission: 164d
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 K924368.
ALBG
K981758 · Abbott Laboratories · Jun 1998
ALBG
K981468 · Abbott Laboratories · May 1998
EMDS ALBUMIN (ALB) TEST
K935179 · Em Diagnostic Systems, Inc. · Dec 1993
ALBUMIN TEST
K923959 · Em Diagnostic Systems, Inc. · Dec 1992
OLYMPUS ALBUMIN REAGENT
K922369 · Olympus Corp. · Jul 1992
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888 · Technicon Instruments Corp. · Nov 1991