Cleared Traditional

K926386 - VISTA PROLACTIN ASSAY

K926386 is the FDA 510(k) clearance for VISTA PROLACTIN ASSAY by Syva Co.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K926386 · Syva Co. · Chemistry device
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Mar 1993
Decision
97d
Days
Class 1
Risk

K926386 is an FDA 510(k) clearance for the VISTA PROLACTIN ASSAY. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on March 29, 1993 after a review of 97 days - within the typical 510(k) review window.

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: 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 Syva Co. devices

Submission Details

510(k) Number K926386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1992
Decision Date March 29, 1993
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
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 K926386.
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994
ACCESS PROLACTIN
K941175 · Bio-Rad Laboratories, Inc. · Jun 1994
COBAS CORE PROLACTIN EIA
K930305 · Roche Diagnostic Systems, Inc. · Aug 1993
IMMULITE PROLACTIN
K925846 · Diagnostic Products Corp. · Mar 1993
AMERLITE PROLACTIN-30 ASSAY
K922170 · Eastman Kodak Company · Sep 1992
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135 · Amersham Corp. · Feb 1992