Cleared Traditional

K924857 - AIA-PACK CEA CALIBRATION VERIFICATION TEST SET

K924857 is an FDA 510(k) clearance for AIA-PACK CEA CALIBRATION VERIFICATION T..., manufactured by Tosoh Medics, Inc.. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 171-day FDA review.

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

FDA 510(k) Submission Details - K924857

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 105d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHX Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K924857.
ELECSYS CEA ON THE ELECSYS 1010
K980887 · Boehringer Mannheim Corp. · Jun 1998
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
K980855 · Dpc Cirrus · Apr 1998
IMMULITE CEA
K970877 · Diagnostic Products Corp. · Sep 1997
TRI-LEVEL LIGAND CONTROL
K864877 · Ciba Corning Diagnostics Corp. · May 1987
CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV
K820298 · Ventrex Laboratories, Inc. · Apr 1982
CEA CONTROL PLASMA
K812658 · Pacific Hemostasis · Sep 1981