Cleared Traditional

K971921 - PROLACTIN (PRL) HORMONE MICROPLATE ELISA

K971921 is the FDA 510(k) clearance for PROLACTIN (PRL) HORMONE MICROPLATE ELISA by Monobind. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K971921 · Monobind · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
32d
Days
Class 1
Risk

K971921 is an FDA 510(k) clearance for the PROLACTIN (PRL) HORMONE MICROPLATE ELISA. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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.

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Submission Details

510(k) Number K971921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date June 24, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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 - CFT Radioimmunoassay, Prolactin (lactogen)

All 50
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K971921.
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
K970281 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
K960561 · Diagnostic Systems Laboratories, Inc. · Apr 1996
DSL ACTIVE PROLACTIN IRMA
K960060 · Diagnostic Systems Laboratories, Inc. · Feb 1996
ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680 · Bio-Rad Laboratories, Inc. · Oct 1995
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
K944698 · Organon Teknika Corp. · Mar 1995