Cleared Traditional

VISTA PROLACTIN ASSAY (K926386) - FDA 510(k) Clearance

Class I Chemistry device.

K926386 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 79
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
AFFINITY PROLACTIN TEST SYSTEM
K902698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · Baxter Healthcare Corp · Jun 1990
ABBOTT IMX PROLACTIN
K896162 · Abbott Laboratories · Jan 1990
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240 · Abbott Laboratories · Sep 1986