Cleared Traditional

AIA-PACK CEA CALIBRATION VERIFICATION TEST SET (K924857) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924857 · Tosoh Medics, Inc. · Immunology device
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Mar 1993
Decision
171d
Days
Class 2
Risk

K924857 is an FDA 510(k) clearance for the AIA-PACK CEA CALIBRATION VERIFICATION TEST SET. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 171 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

Submission Details

510(k) Number K924857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1992
Decision Date March 18, 1993
Days to Decision 171 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 104d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHX System, Test, Carcinoembryonic Antigen
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 - DHX System, Test, Carcinoembryonic Antigen

All 27
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