Cleared Traditional

K931576 - VISTA FERRITIN ASSAY

K931576 is the FDA 510(k) clearance for VISTA FERRITIN ASSAY by Syva Co.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K931576 · Syva Co. · Immunology device
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Aug 1993
Decision
128d
Days
Class 2
Risk

K931576 is an FDA 510(k) clearance for the VISTA FERRITIN ASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on August 5, 1993 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K931576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date August 05, 1993
Days to Decision 128 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 104d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 51
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K931576.
N LATEX FERRITIN
K950707 · Behring Diagnostics, Inc. · Mar 1995
AXSYM FERRITIN
K935847 · Abbott Laboratories · Jun 1994
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1994
CIBA CORNING ACS FERRITIN IMMUNOASSAY
K905770 · Ciba Corning Diagnostics Corp. · Mar 1991
LAN.0800Q/2800Q
K895872 · Amersham Corp. · Oct 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · Amersham Corp. · May 1989