Cleared Traditional

K926422 - VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY

K926422 is an FDA 510(k) clearance for VISTA HUMAN FOLLICLE-STIM HORMONE(HFSH)..., manufactured by Syva Co.. The device is a Class 1 Hematology device with product code GGJ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

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

FDA 510(k) Submission Details - K926422

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.

GGJ Device Classification - Class 1, General Controls

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.