Cleared Traditional

K831535 - E.P.T. PLUS TM

K831535 is the FDA 510(k) clearance for E.P.T. PLUS TM by Warner-Lambert Co.. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831535 · Warner-Lambert Co. · Chemistry device
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Jun 1983
Decision
48d
Days
Class 2
Risk

K831535 is an FDA 510(k) clearance for the E.P.T. PLUS TM. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry 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 Warner-Lambert Co. devices

Submission Details

510(k) Number K831535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1983
Decision Date June 30, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 41
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K831535.
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K831339 · Organon, Inc. · Jun 1983
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K823682 · Organon, Inc. · Jan 1983