ABL800 FLEX with AQURE connectivity

K142898 · Radiometer Medical Aps · CHL · Jun 17, 2015 · Clinical Chemistry

Device Facts

• Record ID: K142898
• Device Name: ABL800 FLEX with AQURE connectivity
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jun 17, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The ABL800 FLEX is intended for use by trained healthcare professionals in a clinical laboratory setting for the in vitro measurement of pH, blood gases, electrolytes, metabolites, and co-oximetry parameters in whole blood samples.

Device Story

Stationary, automated blood gas analyzer; measures pH, pO2, pCO2, electrolytes (K+, Na+, Ca2+, Cl-), metabolites (glucose, lactate, creatinine), bilirubin, and co-oximetry parameters (hemoglobin fractions). Uses potentiometry, amperometry, and spectrophotometry. Modification integrates AQURE connectivity, a Medical Device Data System (MDDS), enabling remote operator data management and initiation of device actions. Operated by clinical staff in professional healthcare settings. Output displayed on touch screen; assists clinicians in diagnosing/monitoring metabolic, respiratory, and renal conditions. Benefits include rapid, accurate point-of-care or lab-based diagnostic data for critical care decision-making.

Clinical Evidence

No clinical data provided. Bench testing only. Performance characteristics remain unchanged from the original and previously modified predicate submissions. Software mitigations were verified against predefined acceptance criteria via test protocols.

Technological Characteristics

Stationary automated analyzer; potentiometry (pH, pCO2, electrolytes), amperometry (pO2, metabolites), and spectrophotometry (co-oximetry). Connectivity via Ethernet (IEEE 802.3) and USB. Software runs on Microsoft XPE. Dimensions: 548x700x476 mm. Weight: 32.9-36.2 kg. Two-point liquid calibration. Menu-driven touch screen interface.

Indications for Use

Indicated for use by trained healthcare professionals in clinical laboratory settings for in vitro diagnostic measurement of pH, 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

• ABL800 FLEX (K041874)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIR: Decision Summary

To: THE FILE
RE: DOCUMENT NUMBER K142898

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 for the ABL800 FLEX with AQURE Connectivity

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.) ABL 800 FLEX - K041874

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 adds remote control capabilities within the laboratory to some of the functions of the analyzer. Remote access to the analyzer by the software (called AQURE) supports the following device actions initiation functions:

- 1 point calibration
- 2 point calibration
- 1 point pH/BG calibration
- Interrupt activity
- Rinse
- Tubing refill
- Liquid sensor adjust
- Cleaning
- Pump calibration
- Lock/Unlock analyzer
- Lock/Unlock parameter
- Set/Get analyzer message
- Enter/Exit standby
- Autocheck measurement
- High Crea Check measurement
- Confirm connection to analyzer
- Add maintenance activity or user activity to schedule

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

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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.