Cleared Traditional

THEOPHYLLINE CONTROL SERUM (K780961) - FDA 510(k) Clearance

Class I Toxicology device.

K780961 · Vitek Systems, Inc. · Toxicology device
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Dec 1978
Decision
178d
Days
Class 1
Risk

K780961 is an FDA 510(k) clearance for the THEOPHYLLINE CONTROL SERUM. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitek Systems, Inc. devices

Submission Details

510(k) Number K780961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1978
Decision Date December 07, 1978
Days to Decision 178 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 87d · This submission: 178d
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 82
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K780961.
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · Beckman Instruments, Inc. · Apr 1997
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119 · Roche Diagnostic Systems, Inc. · Feb 1995
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · Roche Diagnostic Systems, Inc. · Jan 1994
DUPONT ACA URINE METHADONE CONTROL
K934145 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · Roche Diagnostic Systems, Inc. · Jan 1992
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · Roche Diagnostic Systems, Inc. · Aug 1991