Cleared Traditional

K897175 - OLYMPUS DIRECT BILIRUBIN

K897175 is the FDA 510(k) clearance for OLYMPUS DIRECT BILIRUBIN by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K897175 · Em Diagnostic Systems, Inc. · Chemistry device
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Mar 1990
Decision
78d
Days
Class 2
Risk

K897175 is an FDA 510(k) clearance for the OLYMPUS DIRECT 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 March 15, 1990 after a review of 78 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K897175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date March 15, 1990
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
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 168
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K897175.
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
COBAS READY TOTAL BILIRUBIN REAGENT
K896232 · Roche Diagnostic Systems, Inc. · Feb 1990
DIRECT BILIRUBIN REAGENT
K900259 · Medical Analysis Systems, Inc. · Feb 1990
TOTAL BILIRUBIN L.F.
K895822 · Sclavo, Inc. · Nov 1989