Cleared Traditional

K924858 - AIA-PACK FER CALIBRATION VERIFICATION TEST SET

K924858 is an FDA 510(k) clearance for AIA-PACK FER CALIBRATION VERIFICATION T..., manufactured by Tosoh Medics, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K924858 · Tosoh Medics, Inc. · Immunology device
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Dec 1992
Decision
78d
Days
Class 2
Risk

K924858 is an FDA 510(k) clearance for the AIA-PACK FER CALIBRATION VERIFICATION TEST SET. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 15, 1992 after a review of 78 days - a notably fast clearance cycle.

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: 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 - K924858

510(k) Number K924858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date December 15, 1992
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 105d · This submission: 78d
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 K924858.
AXSYM FERRITIN
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K935528 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1994
VISTA FERRITIN ASSAY
K931576 · Syva Co. · Aug 1993
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
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175 · Serono-Baker Diagnostics, Inc. · Apr 1991