Cleared Traditional

K992365 - AIA-PACK FOLATE ASSAY

K992365 is an FDA 510(k) clearance for AIA-PACK FOLATE ASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K992365 · Tosoh Medics, Inc. · Chemistry device
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Aug 1999
Decision
26d
Days
Class 2
Risk

K992365 is an FDA 510(k) clearance for the AIA-PACK FOLATE ASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 26 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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K992365

510(k) Number K992365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1999
Decision Date August 10, 1999
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGN Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K992365.
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
K010050 · Bayer Diagnostics Corp. · Feb 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
K001266 · Ortho-Clinical Diagnostics, Inc. · May 2000
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
K993254 · Diagnostic Products Corp. · Nov 1999
CHIRON DIAGNOSTICS ACS: 180 FOLATE
K991582 · Chiron Diagnostics Corp. · Jun 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3
K984166 · Ortho-Clinical Diagnostics, Inc. · Feb 1999
ABBOTT ARCHITECT FOLATE
K984301 · Abbott Laboratories · Feb 1999