Calibrating Solution for ABL-1 & 2

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K831021 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Total Bilirubin

  Class II

  FDA 510(k) K840111 Active Cleared 19 Mar 1984

• Calibrating Solution for Abl-1 & 2

  Class II

  FDA 510(k) K831018 Active Cleared 16 Jun 1983

• Reagent for Coulter Counter Model 5+11

  Class I

  FDA 510(k) K821683 Active Cleared 24 Jun 1982

• Total Protein Reagent Cs-724

  Class II

  FDA 510(k) K833950 Active Cleared 13 Jan 1984

• Cleaning Solution For Radiometer OSM2

  Class II

  FDA 510(k) K812623 Active Cleared 2 Nov 1981

• Diagnostics Po 2 Electrolyte

  Class II

  FDA 510(k) K831013 Active Cleared 8 Jun 1983

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• What is the primary purpose of this calibrating solution in clinical settings?

  This calibrating solution is designed specifically to validate and calibrate blood gas analyzers (ABL-1 & ABL-2 systems) for accurate measurement of partial pressures of carbon dioxide (PCO₂) and oxygen (PO₂), as well as blood pH. It serves as a reference standard to ensure the precision of electrode-based measurements in whole blood, serum, or plasma, which is critical for reliable clinical chemistry diagnostics.

• Is this solution intended for single-use or repeated use in calibration procedures?

  The solution is supplied as a liquid reagent explicitly for single-use calibration procedures. This design ensures consistency and prevents cross-contamination between calibration cycles, which is important for maintaining accurate measurement standards in clinical laboratories or point-of-care settings.

• What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?

  The device holds a Traditional 510(k) clearance (K831021) under FDA’s Electrode Measurement, Blood-Gases (PCO₂, PO₂) and Blood pH category (regulation number 862.1120). This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for clinical chemistry applications. The clearance does not imply sterility or MRI safety, so users should follow manufacturer guidelines for handling.

• Where and how is this solution typically used, and what sample types does it support?

  This solution is used in clinical laboratories or point-of-care settings to calibrate blood gas analyzers (ABL-1 & ABL-2 systems). It is compatible with whole blood, serum, or plasma samples, ensuring accurate measurement of PCO₂, PO₂, and pH—key parameters for diagnosing and monitoring respiratory, metabolic, and acid-base disorders.

• Are there any specific storage instructions or considerations mentioned for this calibrating solution?

  The provided regulatory data does not include explicit storage conditions for this solution. However, since it is a liquid reagent for single-use calibration, it is advisable to follow the manufacturer’s (Fisher Scientific) recommended storage guidelines—typically involving protection from extreme temperatures, light exposure, and contamination—to maintain its stability and accuracy until use.