Cleared Traditional

OLYMPUS DIRECT BILIRUBIN REAGENT (K923608) - FDA 510(k) Clearance

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

K923608 · Olympus Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
34d
Days
Class 2
Risk

K923608 is an FDA 510(k) clearance for the OLYMPUS DIRECT BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on August 18, 1992 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 K923608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date August 18, 1992
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 78
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K923608.
OLYMPUS TOTAL BILIRUBIN REAGENT
K923609 · Olympus Corp. · Oct 1992
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
K922856 · Em Diagnostic Systems, Inc. · Sep 1992
TOTAL BILIRUBIN CATALOG NO. 65407
K923083 · Em Diagnostic Systems, Inc. · Sep 1992
IL TEST BILIRUBIN TOTAL/DIRECT
K920653 · Instrumentation Laboratory CO · Jul 1992
KODAK EKTACHEM DT SLIDES (NBIL)
K921844 · Eastman Kodak Company · Jul 1992
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · Em Diagnostic Systems, Inc. · Oct 1991