Cleared Traditional

K874782 - COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPR...

K874782 is the FDA 510(k) clearance for COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPR... by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code JLX) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K874782 · Diagnostic Products Corp. · Chemistry device
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Feb 1988
Decision
84d
Days
Class 1
Risk

K874782 is an FDA 510(k) clearance for the COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 84 days - a notably fast clearance cycle.

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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K874782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date February 11, 1988
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
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 K874782.
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K973350 · Bio-Rad · Feb 1998
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)
K943148 · Diagnostic Systems Laboratories, Inc. · Nov 1994
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265 · Diagnostic Systems Laboratories, Inc. · Sep 1989
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K860335 · Diagnostic Products Corp. · Apr 1986