Cleared Traditional

K861511 - EMIT CAFFEINE CONTROL

K861511 is an FDA 510(k) clearance for EMIT CAFFEINE CONTROL, manufactured by Syva / A Syntex Co.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K861511 · Syva / A Syntex Co. · Toxicology device
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Jun 1986
Decision
51d
Days
Class 1
Risk

K861511 is an FDA 510(k) clearance for the EMIT CAFFEINE CONTROL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Syva / A Syntex Co. (Palo Alto, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device 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 Syva / A Syntex Co. devices

FDA 510(k) Submission Details - K861511

510(k) Number K861511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1986
Decision Date June 13, 1986
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 87d · This submission: 51d
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 K861511.
BENZODIAZEPINES TOXICOLOGY CONTROL
K862418 · Utak Laboratories, Inc. · Nov 1986
SERUM VANCOMYCIN TOXICOLOGY CONTROL
K862419 · Utak Laboratories, Inc. · Nov 1986
SERUM CLONAZEPAM TOXICOLOGY CONTROL
K862421 · Utak Laboratories, Inc. · Nov 1986
EMIT 700 CANNABINOID CONTROL SET
K843419 · Syva Co. · Oct 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
MAPROTILINE
K831735 · Utak Laboratories, Inc. · Jul 1983