Cleared Traditional

AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (K880654) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880654 · American Research Products Co. · Chemistry device
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Jun 1988
Decision
111d
Days
Class 2
Risk

K880654 is an FDA 510(k) clearance for the AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200. Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on June 7, 1988 after a review of 111 days - within the typical 510(k) review window.

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 American Research Products Co. devices

Submission Details

510(k) Number K880654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1988
Decision Date June 07, 1988
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIW Calibrator, Surrogate
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 - JIW Calibrator, Surrogate

Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K880654.
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575 · Diagnostic Products Corp. · Oct 1990
ACCUSCAN MICROBEAD STANDARDS
K902294 · Sigma Chemical Co. · Jul 1990
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980