← Product Code [CHL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL) · K123748

# ABL90 FLEX (K123748)

_Radiometer Medical Aps · CHL · May 7, 2013 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K123748

## Device Facts

- **Applicant:** Radiometer Medical Aps
- **Product Code:** [CHL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL.md)
- **Decision Date:** May 7, 2013
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1120
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## 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

ABL90 Flex analyzer; blood gas/oximetry analyzer. Modification: software version 2.6 MR4. Input: blood samples for oximetry parameters. Transformation: updated intralipid correction algorithm reduces interference in oximetry measurements. Output: corrected oximetry parameter values. Used in clinical settings by healthcare professionals. Modification improves measurement accuracy by mitigating intralipid interference.

## Clinical Evidence

Bench testing only; verification and validation activities performed per design control procedures to confirm performance of updated intralipid correction algorithm.

## Technological Characteristics

Software-based modification (version 2.6 MR4) to existing ABL90 Flex analyzer platform. Updates intralipid correction algorithm for oximetry parameters. Fundamental scientific technology unchanged.

## Regulatory 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 ABL90 Flex analyzer (k111897)

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k123748

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) for the ABL90 Flex analyzer:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: Radiometer ABL90 Flex analyzer; k111897.

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 software modification that updates the intralipid correction algorithm for oximetry parameters on ABL90 Flex analyzer. The interference from intralipid to the oximetry parameters was reduced and the Reference Manual was updated to reflect this change. This modification is designated as software version 2.6 MR4.

4. 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K123748](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHL/K123748)

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