Cleared Traditional

K897174 - OLYMPUS(TM) TOTAL BILIRUBIN

K897174 is an FDA 510(k) clearance for OLYMPUS(TM) TOTAL BILIRUBIN, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K897174 · Em Diagnostic Systems, Inc. · Chemistry device
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May 1990
Decision
134d
Days
Class 2
Risk

K897174 is an FDA 510(k) clearance for the OLYMPUS(TM) TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on May 10, 1990 after a review of 134 days - within the typical 510(k) review window.

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: 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K897174

510(k) Number K897174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date May 10, 1990
Days to Decision 134 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
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

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 215
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K897174.
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K902328 · Synermed, Inc. · Jun 1990
COULTER DIRECT BILIRUBIN
K902199 · Coulter Corp. · Jun 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
K902123 · Em Diagnostic Systems, Inc. · Jun 1990
COULTER TOTAL BILIRUBIN REAGENT
K901266 · Coulter Corp. · Apr 1990
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
K900571 · American Research Products Co. · Apr 1990
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
K897176 · Em Diagnostic Systems, Inc. · Mar 1990