Cleared Traditional

K840061 - EMIT ST URINE PHENCYCLIDINE ASSAY

K840061 · Syva Co. · Toxicology device

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Mar 1984

Decision

70d

Days

Risk

K840061 is an FDA 510(k) clearance for the EMIT ST URINE PHENCYCLIDINE ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel. 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	K840061 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 1984
Decision Date	March 19, 1984
Days to Decision	70 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

17d faster than avg

Panel avg: 87d · This submission: 70d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LCM Enzyme Immunoassay, Phencyclidine
Device Class	-

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56

Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K840061.

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS

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EMIT 700 PHENCYCLIDINE ASSAY

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EMIT ST SERUM PHENCYCLIDINE ASSAY

K840199 · Syva Co. · Mar 1984

EMIT-ST SERUM PHENCYCLIDINE ASSAY

K810601 · Syva Co. · Mar 1981

EMIT-ST PHENCYCLIDINE ASSAY

K810093 · Syva Co. · Feb 1981

PHENCYCLIDINE URINE ASSAY

K790401 · Syva Co. · Jun 1979

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 K840061

Syva Co.

Mchenry, IL · 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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