AIA-Pack Fer Calibration Verification Test Set

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K924858 ↗

FDA Product Code

DBF

Device Class

Class II

Regulation

21 CFR Part 866.5340

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Aia-Pack Hgh

  Class I

  FDA 510(k) K905757 Active Cleared 25 Jan 1991

• Aia-Pack Bmg

  Class II

  FDA 510(k) K900440 Active Cleared 26 Feb 1990

• St Aia-Pack Ca 125 Enzyme Immunoassay

  Class II

  FDA 510(k) K023891 Active Cleared 6 Dec 2002

• Aia-Pack Pap Calibration Verification Test Set

  Class I

  FDA 510(k) K924854 Active Cleared 16 Nov 1992

• Aia-Pack Ctni 2ND-Gen Assay

  Class II

  FDA 510(k) K012820 Active Cleared 14 Dec 2001

• Aia-Pack B12 Assay

  Class II

  FDA 510(k) K964348 Active Cleared 13 Jan 1997

See all devices from Tosoh Medics, Inc. →

• What is the primary purpose of the AIA-Pack Fer Calibration Verification Test Set, and how does it function in a laboratory setting?

  The AIA-Pack Fer Calibration Verification Test Set is designed specifically for calibrating and verifying ferritin assays in immunology testing. It includes lyophilized antigen, antiserum, and control reagents in individual test cups, which must be reconstituted before use. This ensures accuracy and consistency in measuring ferritin levels within laboratory testing systems, helping maintain reliable diagnostic results.

• Is the AIA-Pack Fer Calibration Verification Test Set intended for single-use or repeated use, and what are its sterility specifications?

  The device is explicitly labeled as a single-use diagnostic tool and is non-sterile. Since it is meant for laboratory calibration and verification, each test set is intended for one use only to prevent contamination or degradation of the reagents, ensuring consistent performance.

• How should the AIA-Pack Fer Calibration Verification Test Set be stored, and what determines its shelf life?

  The storage conditions and shelf life for the AIA-Pack Fer Calibration Verification Test Set are outlined in the manufacturer’s instructions provided by Tosoh Medics, Inc. While the specific details are not included in the provided data, proper storage is critical to maintaining the integrity of the lyophilized reagents. Always follow the manufacturer’s guidelines to ensure optimal performance and validity.

• What regulatory pathway was followed for the FDA clearance of this device, and what classification does it fall under?

  The AIA-Pack Fer Calibration Verification Test Set received FDA clearance through a 510(k) submission (K924858) under the Traditional clearance type, classified as Class II. The device was determined to be Substantially Equivalent to a predicate device and falls under the Immunology advisory committee (IM). The product code assigned is DBF, corresponding to regulatory category 866.5340.