Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls

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

510(k) Number

K011663 ↗

FDA Product Code

DEM

Device Class

Class II

Regulation

21 CFR Part 866.5130

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Alpha-1-Antitrypsin Immunological Nl Test Kit

  Class II

  FDA 510(k) K913666 Active Cleared 9 Dec 1991

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  Class II

  FDA 510(k) K984163 Active Cleared 2 Feb 1999

• Ena Screening Cie Kit for Diagnostic Use

  Class II

  FDA 510(k) K924262 Active Cleared 29 Dec 1992

• Iga Minineph Antiserum

  Class II

  FDA 510(k) K981786 Active Cleared 24 Nov 1999

• Anticardiolipin Iga Screen Eia Diagnostic Test Kit

  Class II

  FDA 510(k) K983696 Active Cleared 5 Feb 1999

• Human Protein S Rid Test Kit

  Class II

  FDA 510(k) K951640 Active Cleared 21 Apr 1997

See all devices from The Binding Site, Ltd. →

• What is the Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls used for?

  This product is designed to measure alpha-1 antitrypsin protein levels in human serum samples. It provides quantitative reference points (high and low controls) to validate and calibrate assays performed on the Minineph analyzer system, ensuring accurate diagnostic results for conditions related to alpha-1 antitrypsin deficiency.

• How is the Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls supplied and intended for use?

  The controls are supplied as sterile reagents, specifically formulated for single-use in clinical laboratory settings. They are intended exclusively for use with the Minineph analyzer system to verify assay performance and reliability. No additional preparation or special storage conditions are required beyond those outlined in the instructions for use.

• Are these controls reusable or single-use?

  These controls are strictly for single-use only. Each vial is designed to be used once in a laboratory setting to ensure accurate and consistent results. Reusing them could compromise sterility and reliability, leading to potentially inaccurate diagnostic outcomes.

• What regulatory clearance does the Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls hold?

  The product holds an FDA 510(k) clearance under the classification for Alpha-1-Antitrypsin Antigen, Antiserum, and Control, with the clearance number K011663. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets applicable regulatory requirements for in vitro diagnostic use.

• What storage conditions are required for these controls?

  The Minineph A-1 Antitrypsin Antiserum, High and Low Serum Controls do not require special storage conditions beyond those specified in the instructions for use. Standard laboratory storage practices, such as protecting from extreme temperatures and light, should be followed to maintain product integrity until use.