Cleared Traditional

K981289 - N-ASSAY L T-BIL

K981289 is the FDA 510(k) clearance for N-ASSAY L T-BIL by Crestat Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K981289 · Crestat Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
19d
Days
Class 2
Risk

K981289 is an FDA 510(k) clearance for the N-ASSAY L T-BIL. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Seattle, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 19 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 Crestat Diagnostics, Inc. devices

Submission Details

510(k) Number K981289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date April 27, 1998
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
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 169
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K981289.
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
K981883 · Boehringer Mannheim Corp. · Jul 1998
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
K981609 · Diagnostic Chemicals , Ltd. · Jun 1998
TBIL
K981336 · Abbott Laboratories · May 1998
DIRECT BILIRUBIN (DBIL)
K981222 · Abbott Laboratories · Apr 1998
BILIRUBIN-SL (TOTAL) ASSAY
K974874 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1998
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
K973109 · Synermed, Inc. · Sep 1997