Cleared Traditional

K892801 - CLINISTAT TOTAL BILIRUBIN REAGENT TEST

K892801 is the FDA 510(k) clearance for CLINISTAT TOTAL BILIRUBIN REAGENT TEST by Heraeus Kulzer, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K892801 · Heraeus Kulzer, Inc. · Chemistry device
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Aug 1989
Decision
120d
Days
Class 2
Risk

K892801 is an FDA 510(k) clearance for the CLINISTAT TOTAL BILIRUBIN REAGENT TEST. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 120 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K892801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date August 15, 1989
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 176
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K892801.
TOTAL BILIRUBIN L.F.
K895822 · Sclavo, Inc. · Nov 1989
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
K895118 · Em Diagnostic Systems, Inc. · Oct 1989
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
K895119 · Em Diagnostic Systems, Inc. · Oct 1989
DIRECT BILIRUBIN REAGENT
K893730 · Medical Analysis Systems, Inc. · Aug 1989
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
K892668 · Catachem, Inc. · Jul 1989
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
K892905 · Catachem, Inc. · Jun 1989