Cleared Traditional

K931576 - VISTA FERRITIN ASSAY

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

K931576 · Syva Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K931576

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
23d slower than avg
Panel avg: 105d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

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 73
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
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
K924858 · Tosoh Medics, Inc. · Dec 1992
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
K920952 · Vitek Systems, Inc. · Apr 1992
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046 · Medix Biotech, Inc. · Jan 1992