Cleared Traditional

K010796 - AIA-PACK BRCA, ST AIA PACK BRCA

K010796 is an FDA 510(k) clearance for AIA-PACK BRCA, manufactured by Tosoh Medics, Inc.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K010796 · Tosoh Medics, Inc. · Immunology device
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Aug 2001
Decision
153d
Days
Class 2
Risk

K010796 is an FDA 510(k) clearance for the AIA-PACK BRCA, ST AIA PACK BRCA. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on August 16, 2001 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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 Tosoh Medics, Inc. devices

FDA 510(k) Submission Details - K010796

510(k) Number K010796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2001
Decision Date August 16, 2001
Days to Decision 153 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
48d slower than avg
Panel avg: 105d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOI Device Classification - Class 2, Special Controls

Product Code MOI System, Test, Immunological, Antigen, Tumor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - MOI System, Test, Immunological, Antigen, Tumor

All 27
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K010796.
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · Bayer Diagnostics Corp. · Nov 2002
IMMULITE BR-MA, MODEL #LKBR
K013984 · Diagnostic Products Corp. · Mar 2002
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K012357 · Bayer Diagnostics Corp. · Feb 2002
ELECSYSCA 15-3 II ASSAY
K010588 · Roche Diagnostics Corp. · Mar 2001
ELECSYS CA 15-3 TEST SYSTEM
K001468 · Roche Diagnostics Corp. · Oct 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
K983690 · Ortho-Clinical Diagnostics, Inc. · Feb 1999