Cleared Traditional

K873011 - QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2

K873011 is an FDA 510(k) clearance for QUANTIMETRIX SERUM ALCOHOL CONTROL LEVE..., manufactured by Quantimetrix Medical Industries. The device is a Class 1 Chemistry device with product code LAS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K873011 · Quantimetrix Medical Industries · Chemistry device
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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

FDA 510(k) Submission Details - K873011

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.

LAS Device Classification - Class 1, General Controls

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 71
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
DIGOXIN FPIA CONTROLS
K872347 · Sigma Diagnostics, Inc. · Jul 1987
PHENYTOIN FPIA CONTROLS
K871567 · Sigma Diagnostics, Inc. · Jul 1987
BENZODIAZEPINES TOXICOLOGY CONTROL
K862418 · Utak Laboratories, Inc. · Nov 1986