Cleared Traditional

K840194 - EMIT ST SERUM BARBITURATE ASSAY

K840194 is the FDA 510(k) clearance for EMIT ST SERUM BARBITURATE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K840194 · Syva Co. · Toxicology device

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Mar 1984

Decision

61d

Days

Class 2

Risk

K840194 is an FDA 510(k) clearance for the EMIT ST SERUM BARBITURATE ASSAY. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 61 days - a notably fast clearance cycle.

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: 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	K840194 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1984
Decision Date	March 19, 1984
Days to Decision	61 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

26d faster than avg

Panel avg: 87d · This submission: 61d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 67

Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K840194.

EMIT D.A.U. BARBITURATE ASSAY

K842675 · Syva Co. · Sep 1984

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

MODIF. OF EMIT URINE BARBITURATE

K833577 · Syva Co. · Jan 1984

EMIT-ST SERUM BARBITURATE ASSAY

K810602 · Syva Co. · Apr 1981

EMIT-STM BARBITURATE ASSAY

K802617 · Syva Co. · Oct 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K840194

Syva Co.

Walker, MI · US

Regulatory profile

448 submissions 447 cleared

100% clearance rate · Active in Toxicology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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