Cleared Traditional

K882059 - BILIRUBIN STANDARD

K882059 is an FDA 510(k) clearance for BILIRUBIN STANDARD, manufactured by Verichem Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K882059 · Verichem Laboratories, Inc. · Chemistry device
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Oct 1988
Decision
162d
Days
Class 2
Risk

K882059 is an FDA 510(k) clearance for the BILIRUBIN STANDARD. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 162 days - an extended review 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: 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 Verichem Laboratories, Inc. devices

FDA 510(k) Submission Details - K882059

510(k) Number K882059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1988
Decision Date October 25, 1988
Days to Decision 162 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 88d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

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 211
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K882059.
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