Cleared Traditional

K892801 - CLINISTAT TOTAL BILIRUBIN REAGENT TEST

K892801 is an FDA 510(k) clearance for CLINISTAT TOTAL BILIRUBIN REAGENT TEST, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K892801

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.

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 218
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