Cleared Traditional

K993219 - WAKO BILIRUBIN CALIBRATOR

K993219 is the FDA 510(k) clearance for WAKO BILIRUBIN CALIBRATOR by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K993219 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
43d
Days
Class 2
Risk

K993219 is an FDA 510(k) clearance for the WAKO BILIRUBIN CALIBRATOR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K993219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date November 09, 1999
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K993219.
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114 · Dade Behring, Inc. · Jan 2000
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
K994325 · Beckman Coulter, Inc. · Jan 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
K994145 · Ortho-Clinical Diagnostics, Inc. · Dec 1999
SYNCHRON SYSTEMS LIPID CALIBRATOR
K983640 · Beckman Coulter, Inc. · Dec 1998
AUTO HDL CHOLESTEROL CALIBRATOR
K970933 · Pointe Scientific, Inc., · May 1997
WAKO DIRECT HDL-C
K963847 · Wako Chemicals USA, Inc. · Dec 1996