MODIFICATION TO ABL800 FLEX

K050869 · Radiometer Medical Aps · CIG · Aug 11, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050869
• Device Name: MODIFICATION TO ABL800 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CIG · Clinical Chemistry
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids.

Device Story

RADIANCE v2.5 is a Windows-based software application running on an independent server; interfaces with ABL800 FLEX blood-gas analyzers. Enables remote data entry and control of analyzers connected to laboratory (LIS) or hospital (HIS) information systems. Includes AutoCheck Module for automated quality control fluid analysis. Used by laboratory personnel to manage analyzer data and connectivity; facilitates centralized monitoring and control of diagnostic testing workflows.

Clinical Evidence

No clinical data provided; substantial equivalence based on design controls and technological similarity to the predicate device.

Technological Characteristics

Windows-based software application; server-based architecture; connectivity to LIS/HIS; includes AutoCheck Module for automated quality control analysis.

Indications for Use

Indicated for in vitro diagnostic testing of whole blood and expired air samples for blood gas, electrolyte, metabolite, and co-oximetry parameters in clinical settings.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

• K041874

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K050869

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.) 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, tracking of sample capabilities, management of sample capabilities and new exporting, reporting, archiving and data management capabilities.

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