Cleared Traditional

N-ASSAY L T-BIL (K981289) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 234
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K981289.
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · Siemens Healthcare Diagnostics, Inc. · Jun 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Total Bilirubin2
K223324 · Abbott Ireland Diagnostics Division · Dec 2022
VITROS XT Chemistry Products TBIL-ALKP Slides
K190807 · Ortho-Clinical Diagnostics, Inc. · Apr 2019
Total Bilirubin
K150510 · Abbott Laboratories · Apr 2015