Cleared Traditional

K954680 - ACCESS PROLACTIN ASSAY (MODIFICATION)

K954680 is the FDA 510(k) clearance for ACCESS PROLACTIN ASSAY (MODIFICATION) by Bio-Rad Laboratories, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K954680 · Bio-Rad Laboratories, Inc. · Chemistry device
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Oct 1995
Decision
18d
Days
Class 1
Risk

K954680 is an FDA 510(k) clearance for the ACCESS PROLACTIN ASSAY (MODIFICATION). Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 18 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.

View all Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K954680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date October 20, 1995
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 44
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K954680.
ELECSYS PROLACTIN ASSAY
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DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
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DSL ACTIVE PROLACTIN IRMA
K960060 · Diagnostic Systems Laboratories, Inc. · Feb 1996
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
K944698 · Organon Teknika Corp. · Mar 1995
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K943811 · Biomerieux Vitek, Inc. · Nov 1994
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994