Cleared Traditional

VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY (K926422) - FDA 510(k) Clearance

Class I Hematology device.

K926422 · Syva Co. · Hematology device
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Jun 1993
Decision
161d
Days
Class 1
Risk

K926422 is an FDA 510(k) clearance for the VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY. Classified as Fluid, Diluting, White-cell (product code GGJ), Class I - General Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on June 2, 1993 after a review of 161 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K926422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date June 02, 1993
Days to Decision 161 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 113d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GGJ Fluid, Diluting, White-cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
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.