Cleared Traditional

K935230 - EMIT IIC NEGATIVE CONTROL

K935230 is the FDA 510(k) clearance for EMIT IIC NEGATIVE CONTROL by Syva Co.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K935230 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
63d
Days
Class 1
Risk

K935230 is an FDA 510(k) clearance for the EMIT IIC NEGATIVE CONTROL, CONTROL I AND II. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on January 3, 1994 after a review of 63 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 Co. devices

Submission Details

510(k) Number K935230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date January 03, 1994
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture 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 - DIF Drug Mixture Control Materials

All 131
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K935230.
DOA LIQUID DRUGS OF ABUSE CONTROLS
K934498 · Medical Analysis Systems, Inc. · Jul 1994
CEDIA DAU CONTROLS
K934650 · Medical Analysis Systems, Inc. · Apr 1994
DRUGS OF ABUSE CONTROLS
K935285 · Medical Diagnostic Technologies, Inc. · Mar 1994
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · Roche Diagnostic Systems, Inc. · Aug 1993
ABUSCREEN ONLINE CONTROL
K931125 · Roche Diagnostic Systems, Inc. · Aug 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · Bio-Rad · Jul 1993