Cleared Traditional

K780732 - PROCAINAMIDE CALIBRATOR KIT

K780732 is the FDA 510(k) clearance for PROCAINAMIDE CALIBRATOR KIT by Vitek Systems, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K780732 · Vitek Systems, Inc. · Toxicology device
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Nov 1978
Decision
204d
Days
Class 2
Risk

K780732 is an FDA 510(k) clearance for the PROCAINAMIDE CALIBRATOR KIT. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Vitek Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 204 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 K780732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1978
Decision Date November 22, 1978
Days to Decision 204 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 87d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K780732.
EMIT-D.A.U. PHENCYCLIDINE URINE LOW
K790398 · Syva Co. · Jun 1979
URINE MEDIUM CALIBRATOR
K790399 · Syva Co. · Jun 1979
LIDOCAINE CALIBRATOR KIT
K780731 · Vitek Systems, Inc. · Jan 1979
EMIT THEOPHYLLINE CONTROL
K772166 · Syva Co. · Nov 1977
EMIT LIDOCAINE CONTROL
K772167 · Syva Co. · Nov 1977
ACA ALCOHOL CALIBRATORS
K771799 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977