Cleared Traditional

K934121 - VISTA FOLATE ASSAY

K934121 is the FDA 510(k) clearance for VISTA FOLATE ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K934121 · Syva Co. · Chemistry device
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Oct 1993
Decision
58d
Days
Class 2
Risk

K934121 is an FDA 510(k) clearance for the VISTA FOLATE ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on October 22, 1993 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syva Co. devices

Submission Details

510(k) Number K934121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date October 22, 1993
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K934121.
FOLIC ACID
K943705 · Diagnostic Products Corp. · Oct 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · Beckman Coulter, Inc. · Aug 1994
QUANTAPHASE II B12/FOLATE
K935286 · Bio-Rad · Feb 1994
ACCESS FOLATE ASSAY
K932887 · Beckman Coulter, Inc. · Oct 1993
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571 · Bio-Rad · Oct 1993
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
K923286 · Baxter Diagnostics, Inc. · Sep 1992