ABL90 FLEX PLUS

K160153 · Radiometer Medical Aps · CHL · Nov 4, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160153
• Device Name: ABL90 FLEX PLUS
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ABL90 FLEX PLUS is intended for use by trained healthcare professionals in a clinical environment for the in vitro measurement of blood gases, electrolytes, metabolites, and co-oximetry parameters in whole blood samples.

Device Story

Portable, automated in vitro diagnostic analyzer for heparinized whole blood/capillary samples; measures pH, blood gases, electrolytes, glucose, lactate, and oximetry. Features a mechanized inlet module (AutoInlet) and 'Short Probe Mode' for reduced sample volume, replacing manual inlet clips. Operated by trained clinicians in lab or point-of-care settings. Provides quantitative results to aid clinical decision-making for acid-base, electrolyte, and metabolic conditions. Benefits include streamlined sample handling and reduced volume requirements for neonatal/point-of-care testing.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of hardware and software modifications.

Technological Characteristics

Portable analyzer using potentiometry, amperometry, and spectrophotometry. Components: sensor cassette, solution pack, mechanized inlet module. Software-controlled inlet and measurement modes. No specific material standards cited.

Indications for Use

Indicated for use by healthcare professionals for in vitro diagnostic measurement of blood gases, electrolytes, metabolites, and co-oximetry parameters in whole blood samples.

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

• ABL90 FLEX (K132691)
• ABL90 FLEX (K131988)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER: k160153

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.)

ABL90 FLEX, k131988 and k132691

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 the following items:

a. Modifications to instrument hardware related to sample introduction and user interaction.
b. Modifications to instrument hardware to eliminate use of special adaptor (ABL90 FLEX Inlet Clip) previously required when using third party blood sampler syringes.
c. Modification to the software to implement the sample introduction hardware.
d. Minor changes in visual appearance of the instrument.
e. Modifications to user manual to reflect the changes to the device and improve content.
f. The trade name is changed from ABL90 FLEX to ABL90 FLEX PLUS.

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

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

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.