Cleared Traditional

K882059 - BILIRUBIN STANDARD

K882059 is the FDA 510(k) clearance for BILIRUBIN STANDARD by Verichem Laboratories, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 151
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K882059.
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648 · Ventrex Laboratories, Inc. · Jan 1990
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
K895649 · Ventrex Laboratories, Inc. · Jan 1990
CHLORIDE STANDARDS ITEM #SR1041
K891999 · Em Diagnostic Systems, Inc. · Aug 1989
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
K882259 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1988
PARAMAX ISE CHLORIDE CALIBRATOR
K873743 · Baxter Healthcare Corp · Dec 1987
G-GT STANDARD CALIBRATOR
K871759 · Wako Chemicals USA, Inc. · Sep 1987