Cleared Traditional

K943148 - DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL...

K943148 is the FDA 510(k) clearance for DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL... by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Chemistry device (product code JLX) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K943148 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Nov 1994
Decision
133d
Days
Class 1
Risk

K943148 is an FDA 510(k) clearance for the DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000). Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on November 10, 1994 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1395 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K943148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1994
Decision Date November 10, 1994
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLX Radioimmunoassay, 17-hydroxyprogesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1395
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 - JLX Radioimmunoassay, 17-hydroxyprogesterone

Devices cleared under the same product code (JLX) and FDA review panel - the closest regulatory comparables to K943148.
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K973350 · Bio-Rad · Feb 1998
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265 · Diagnostic Systems Laboratories, Inc. · Sep 1989
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT
K874782 · Diagnostic Products Corp. · Feb 1988
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K860335 · Diagnostic Products Corp. · Apr 1986