Cleared Traditional

K833577 - MODIF. OF EMIT URINE BARBITURATE

K833577 is an FDA 510(k) clearance for MODIF. OF EMIT URINE BARBITURATE, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K833577 · Syva Co. · Toxicology device
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Jan 1984
Decision
106d
Days
Class 2
Risk

K833577 is an FDA 510(k) clearance for the MODIF. OF EMIT URINE BARBITURATE. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 Syva Co. devices

FDA 510(k) Submission Details - K833577

510(k) Number K833577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 26, 1984
Days to Decision 106 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
19d slower than avg
Panel avg: 87d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K833577.
EMIT 700 BARBITURATE ASSAY
K843418 · Syva Co. · Sep 1984
ACA BARBITURATES SCREEN ANALY TEST PACK
K842783 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
EMIT ST SERUM BARBITURATE ASSAY
K840194 · Syva Co. · Mar 1984
EMIT-ST SERUM BARBITURATE ASSAY
K810602 · Syva Co. · Apr 1981
EMIT-STM BARBITURATE ASSAY
K802617 · Syva Co. · Oct 1980
EMIT-BARBITURATE ASSAY
K792114 · Syva Co. · Dec 1979