Cleared Traditional

K053090 - DRI-STAT ENZYMATIC BILIRUBIN REAGENT

K053090 is the FDA 510(k) clearance for DRI-STAT ENZYMATIC BILIRUBIN REAGENT by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code JFM) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K053090 · Beckman Coulter, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
44d
Days
Class 2
Risk

K053090 is an FDA 510(k) clearance for the DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR. Classified as Enzymatic Method, Bilirubin (product code JFM), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 16, 2005 after a review of 44 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K053090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2005
Decision Date December 16, 2005
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFM Enzymatic Method, 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 - JFM Enzymatic Method, Bilirubin

All 8
Devices cleared under the same product code (JFM) and FDA review panel - the closest regulatory comparables to K053090.
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · Bayer Healthcare, LLC · Dec 2007
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · Wako Chemicals USA, Inc. · Dec 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132 · Wako Chemicals USA, Inc. · Dec 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
K050266 · Stanbio Laboratory · Jun 2005
WAKO TOTAL BILIRUBIN V
K970985 · Wako Chemicals USA, Inc. · Apr 1997
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660 · Diagnostic Chemicals, Ltd. (Usa) · Nov 1990