Cleared Traditional

K926394 - VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY

K926394 is an FDA 510(k) clearance for VISTA HUMAN LUTEINIZING HORMONE(HLH) ASSAY, manufactured by Syva Co.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 156-day FDA review.

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

FDA 510(k) Submission Details - K926394

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.

CEP Device Classification - Class 1, General Controls

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 101
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K926394.
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
K943996 · Dupont Medical Products · Oct 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · Vitek Systems, Inc. · Apr 1992
LH GEN III SELF-TEST/CONCEIVE
K920160 · Quidel Corp. · Mar 1992