Cleared Traditional

K944933 - IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)

K944933 is an FDA 510(k) clearance for IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN), manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code JMF cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K944933 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
155d
Days
Class 2
Risk

K944933 is an FDA 510(k) clearance for the IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN). Classified as Radioimmunoassay, Human Placental Lactogen (product code JMF), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1585 - 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 Products Corp. devices

FDA 510(k) Submission Details - K944933

510(k) Number K944933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1994
Decision Date March 10, 1995
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JMF Device Classification - Class 2, Special Controls

Product Code JMF Radioimmunoassay, Human Placental Lactogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1585
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 - JMF Radioimmunoassay, Human Placental Lactogen

All 8
Devices cleared under the same product code (JMF) and FDA review panel - the closest regulatory comparables to K944933.
AMERLEX HUMAN PLACENTAL LACTOGEN
K840588 · Amersham Corp. · Apr 1984
IMMOPHASE TM HPL RADIOIMMUNOASSAY
K823292 · Corning Medical & Scientific · Dec 1982
HUMAN PLACENTAL LACTOGEN KIT
K823201 · Diagnostic Products Corp. · Nov 1982
NATAL-TEC HPL
K811370 · Armkel, LLC · May 1981
GESTE FOLLOW KIT DETERM. OF HPL
K802454 · Syn-Kit, Inc. · Nov 1980
CENTRIA HPL RIA
K791854 · Union Carbide Corp. · Oct 1979