Cleared Traditional

K970985 - WAKO TOTAL BILIRUBIN V

K970985 is the FDA 510(k) clearance for WAKO TOTAL BILIRUBIN V by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code JFM) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K970985 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
34d
Days
Class 2
Risk

K970985 is an FDA 510(k) clearance for the WAKO TOTAL BILIRUBIN V. Classified as Enzymatic Method, Bilirubin (product code JFM), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on April 21, 1997 after a review of 34 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K970985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1997
Decision Date April 21, 1997
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K970985.
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
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660 · Diagnostic Chemicals, Ltd. (Usa) · Nov 1990
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
K843174 · Beckman Instruments, Inc. · Sep 1984