Cleared Traditional

K872263 - TOTAL BILIRUBIN STANDARD CALIBRATOR

K872263 is the FDA 510(k) clearance for TOTAL BILIRUBIN STANDARD CALIBRATOR by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K872263 · Wako Chemicals USA, Inc. · Chemistry device
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Jul 1987
Decision
40d
Days
Class 2
Risk

K872263 is an FDA 510(k) clearance for the TOTAL BILIRUBIN STANDARD CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on July 22, 1987 after a review of 40 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 K872263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1987
Decision Date July 22, 1987
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K872263.
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BILE ACIDS CALIBRATOR
K872451 · Sigma Diagnostics, Inc. · Aug 1987
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K871756 · Wako Chemicals USA, Inc. · May 1987
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8
K871150 · Beckman Instruments, Inc. · May 1987
GLUCOSE STANDARD SOLUTION CALIBRATOR
K871758 · Wako Chemicals USA, Inc. · May 1987