ABL90 FLEX

K122729 · Radiometer Medical Aps · CHL · Nov 16, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122729
• Device Name: ABL90 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Nov 16, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

Device Story

The ABL90 FLEX is a portable, automated analyzer for in vitro diagnostic testing of heparinized whole blood. It measures pH, blood gases, electrolytes, glucose, lactate, and oximetry parameters. The device uses potentiometry for blood gases and electrolytes, amperometry for metabolites (glucose, lactate), and spectrophotometry for hemoglobin fractions. It is operated by trained healthcare professionals in clinical or point-of-care settings. The device modification introduces a software-based suppression feature: if the sample pO2 is below 25 mmHg, the analyzer suppresses the glucose result and displays "Glu not usable" to prevent reporting falsely low glucose values caused by oxygen-dependent glucose oxidase interference. This ensures clinical decision-making is based on reliable glucose data, benefiting patients by avoiding inaccurate metabolic assessments.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm software correctly identifies pO2 < 25 mmHg and suppresses glucose results.

Technological Characteristics

Portable, automated analyzer. Sensing principles: potentiometry (pH, pO2, pCO2, electrolytes), amperometry (glucose, lactate), spectrophotometry (hemoglobin). Connectivity: touch screen interface. Software: Microsoft XPE operating system. Modification: software-based threshold logic for result suppression based on pO2 input.

Indications for Use

Indicated for use with the Radiometer ABL 90 Flex Analyzer for blood gas and metabolite analysis in clinical settings.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• Radiometer ABL 90 Flex Analyzer (k092686)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k122729

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Radiometer ABL 90 Flex Analyzer k092686

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A modification in the labeling and software to assure that the operator does not use glucose results obtained from samples with a pO2 level below 25 mmHg. The message "Glu not usable" displays on the ABL 90 Flex Analyzer computer screen when pO2 levels are less than 25 mmHg.

3. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.