Cleared Traditional

K942051 - SR1 DHEA-S ENZYME IMMUNOASSAY

K942051 is an FDA 510(k) clearance for SR1 DHEA-S ENZYME IMMUNOASSAY, manufactured by Serono Diagnostics, Inc.. The device is a Class 1 Toxicology device with product code JKC cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K942051 · Serono Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
76d
Days
Class 1
Risk

K942051 is an FDA 510(k) clearance for the SR1 DHEA-S ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (product code JKC), Class I - General Controls.

Submitted by Serono Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on July 13, 1994 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1245 - 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 Serono Diagnostics, Inc. devices

FDA 510(k) Submission Details - K942051

510(k) Number K942051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date July 13, 1994
Days to Decision 76 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 87d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

JKC Device Classification - Class 1, General Controls

Product Code JKC Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1245
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JKC Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

All 17
Devices cleared under the same product code (JKC) and FDA review panel - the closest regulatory comparables to K942051.
DHEA-S
K973897 · Kmi Diagnostics, Inc. · Nov 1997
DSL DHEA-S-7
K962895 · Diagnostic Systems Laboratories, Inc. · Sep 1996
DSL AACTIVE DHEA EIA KIT
K955114 · Diagnostic Systems Laboratories, Inc. · Feb 1996
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
K935014 · Diagnostic Systems Laboratories, Inc. · May 1994
IMMULITE DHEA-S04
K935806 · Diagnostic Products Corp. · Apr 1994
SYNELISA DHEA-SULFATE
K935469 · Elias U.S.A., Inc. · Mar 1994