Cleared Traditional

QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2 (K873011) - FDA 510(k) Clearance

Class I Chemistry device.

K873011 · Quantimetrix Medical Industries · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
86d
Days
Class 1
Risk

K873011 is an FDA 510(k) clearance for the QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Quantimetrix Medical Industries (Hawthorne, US). The FDA issued a Cleared decision on October 29, 1987 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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 Quantimetrix Medical Industries devices

Submission Details

510(k) Number K873011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date October 29, 1987
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 42
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K873011.
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
K893860 · Roche Diagnostic Systems, Inc. · Aug 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004 · Bio-Rad · Apr 1989
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
K883891 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1988
EMIT 700 CANNABINOID CONTROL SET
K843419 · Syva Co. · Oct 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
K831979 · Syva Co. · Jul 1983