Cleared Traditional

K811622 - EMIT-ST SERUM PHENOBARBITAL CALIBRATOR

K811622 is the FDA 510(k) clearance for EMIT-ST SERUM PHENOBARBITAL CALIBRATOR by Syva Co.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811622 · Syva Co. · Toxicology device
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Jun 1981
Decision
17d
Days
Class 2
Risk

K811622 is an FDA 510(k) clearance for the EMIT-ST SERUM PHENOBARBITAL CALIBRATOR. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on June 25, 1981 after a review of 17 days - a notably fast clearance 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: 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 K811622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1981
Decision Date June 25, 1981
Days to Decision 17 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
70d faster than avg
Panel avg: 87d · This submission: 17d
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 K811622.
ADVANCE EMIT-CAD QUINIDINE CONTROL
K822587 · Syva Co. · Sep 1982
EMIT D.A.V. METHAQUALONE URINE CALIBRA
K822052 · Syva Co. · Jul 1982
EMIT-ST CANNABINOID CALIBRATOR
K812197 · Syva Co. · Aug 1981
EMIT -D.A.U. CANNABINOID URINE CALIBS.
K800247 · Syva Co. · Feb 1980
EMIT-D.A.U. PHENCYCLIDINE URINE LOW
K790398 · Syva Co. · Jun 1979
URINE MEDIUM CALIBRATOR
K790399 · Syva Co. · Jun 1979