Cleared Traditional

VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY (K926394) - FDA 510(k) Clearance

Class I Chemistry device.

K926394 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
156d
Days
Class 1
Risk

K926394 is an FDA 510(k) clearance for the VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 156 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 K926394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date May 26, 1993
Days to Decision 156 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
68d slower than avg
Panel avg: 88d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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 - CEP Radioimmunoassay, Luteinizing Hormone

All 142
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K926394.
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · Abbott Laboratories · Mar 1989
ABBOTT IMX LH
K884138 · Abbott Laboratories · Nov 1988