Cleared Traditional

K152343 - Direct Bilirubin

K152343 is an FDA 510(k) clearance for Direct Bilirubin, manufactured by Randox Laboratories Limited. The device is a Class 2 Chemistry device with product code JFM cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K152343 · Randox Laboratories Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
181d
Days
Class 2
Risk

K152343 is an FDA 510(k) clearance for the Direct Bilirubin. Classified as Enzymatic Method, Bilirubin (product code JFM), Class II - Special Controls.

Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on February 16, 2016 after a review of 181 days - an extended review 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: 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 Randox Laboratories Limited devices

FDA 510(k) Submission Details - K152343

510(k) Number K152343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2015
Decision Date February 16, 2016
Days to Decision 181 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
93d slower than avg
Panel avg: 88d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFM Device Classification - Class 2, Special Controls

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 9
Devices cleared under the same product code (JFM) and FDA review panel - the closest regulatory comparables to K152343.
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
K170065 · Siemens Healthcare Diagnostics, Inc. · Mar 2017
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
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090 · Beckman Coulter, Inc. · Dec 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
K050266 · Stanbio Laboratory · Jun 2005