Cleared Traditional

K924368 - OLYMPUS ALBUMIN REAGENT

K924368 is an FDA 510(k) clearance for OLYMPUS ALBUMIN REAGENT, manufactured by Olympus Corp.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 164-day FDA review.

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

FDA 510(k) Submission Details - K924368

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.

CIX Device Classification - Class 2, Special Controls

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 106
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K924368.
DMA ALBUMIN PROCEDURE
K946355 · Data Medical Associates, Inc. · Mar 1995
ALBUMIN QVET
K943000 · Prisma Systems · Dec 1994
EMDS ALBUMIN (ALB) TEST
K935179 · Em Diagnostic Systems, Inc. · Dec 1993
ALBUMIN TEST
K923959 · Em Diagnostic Systems, Inc. · Dec 1992
TRACE ALBUMIN-MR REAGENT
K923322 · Trace Scientific , Ltd. · Sep 1992
OLYMPUS ALBUMIN REAGENT
K922369 · Olympus Corp. · Jul 1992