ABL90 FLEX

K120197 · Radiometer Medical Aps · CHL · Mar 19, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120197
• Device Name: ABL90 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinised whole blood. The ABL90 FLEX 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

Radiometer ABL 90 Flex Analyzer; blood gas/electrolyte/metabolite analyzer. Modification adds remote control capabilities via Netop host/client OTS software. Remote functions: perform calibrations, initiate replacement procedures, perform QC measurements, edit log file data (patient demographics, input parameters, sample notes), and approve patient results. Device used in clinical settings; operated by healthcare professionals. Remote access allows off-device management of analyzer functions; does not alter patient results. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data. Bench testing and design control verification/validation activities performed to assess the impact of the software modification.

Technological Characteristics

Portable, automated analyzer. Measurement principles: potentiometry (pH, blood gases, electrolytes), amperometry (glucose, lactate), spectrophotometry (hemoglobin). Software: Microsoft XPE operating system. Connectivity: Netop™ integration for remote access. Power: 230/120 V mains. Sample introduction: aspiration.

Indications for Use

Indicated for use by trained clinicians (technologists, nurses, physicians, therapists) in lab or point-of-care settings to measure pH, blood gases, electrolytes (K+, Na+, Ca2+, Cl-), glucose, lactate, and oximetry parameters (ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF) in heparinized whole blood for the diagnosis and treatment of acid-base, electrolyte, metabolic, and hemoglobin-related disorders.

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 to ABL90 Flex

### Section 5. 510(k) Summary

120197

MAR 1 9 2012

#### 1. Administrative

Device Information Device Name: Common Name: Product Code: Registration Number: Classification : Classification Panel:

ABL90 Flex Blood gases and blood pH test system CHL (JGS, CEM; JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX) 21 CFR 862.1120 Class II Clinical Chemistry

Submitter . Company Name: ER Number: .

Address:

Phone:

Fax:

Radiometer Medical ApS 3002807968 Aakandevej 21 2700 Broenshoej Denkmark 445 3827 3827 [phone]

#### 2. Description of Device Modification

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).

The integration with Netop™ allows remote operators to access a specific ABL90 Flex analyser and to execute a number of predefined functions.

#### 3. Intended Use

The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinised whole blood. The ABL90 FLEX 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.

#### 4. Substantial Equivalence

The ABL90 FLEX with the integration with Netop™ is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:

#### 510(k) Number/Device Manufacturer: K092686 ABL90 Flex, Radiometer Medical ApS

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| Predicate: ABL90 Flex (K092686) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | Differences |
| Intended Use<br>The ABL90 FLEX is a portable, automated<br>analyzer that measures pH, blood gases,<br>electrolytes, glucose, lactate and oximetry in<br>heparinised whole blood. The ABL90 FLEX is<br>intended for use by trained technologists,<br>nurses, physicians and therapists. It is<br>intended for use in a laboratory environment,<br>near patient or point-of-care setting. | Remote access to the analyser by the Netop<br>host/client OTS software supporting the<br>following functions:<br>- Perform calibrations,<br>- Perform replacements,<br>- Perform QC measurements,<br>- Edit data in the log files, and<br>- Approve patient results. |
| Blood Gas Measurement<br>pH, pO2, pCO2 by potentiometry | |
| Electrolyte Measurement<br>cK+, cNa+, cCa2+, cCl- by potentiometry | |
| Metabolite Measurement<br>cGlu, cLac by amperometry | |
| Oximetry Measurement<br>ctHb, sO2 FO2Hb, FHHb, FCOHb, FMetHb,<br>FHbF | |
| Hemoglobin Measurement<br>Spectrophotometry | |
| Identical Performance Characteristics<br>Two-Point liquid calibration | |
| Menu driven touch screen | |
| Software operating system<br>Microsoft XPE | |
| Sample Introduction<br>Aspiration | |
| Dimensions (length x width x depth) | |
| External Power Source<br>230/120 V mains | |

### 5. Performance Data

No performance characteristics are affected by the change. The performance data submitted in K092686 still apply.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Radiometer Medical ApS c/o Martin Gabler Aakandevej 21 Denkmark DK-2700

MAR 1 9 2012

k120197 Re:

Trade Name: ABL90 Flex Regulation Number: 21 CFR §862.1120 Regulation Name: Blood Gases and blood pH test system Regulatory Class: Class II Product Codes: CHL, CEM, CGA, CGZ, GHS, GKR, JFP, JGS, JIX, KQI, JJY, KHP Dated: February 28, 2012 Received: March 2, 2012

Dear Mr. Gabler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k120197

Device Name: ABL90 FLEX Analyzer

Indications For Use:

The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases. electrolytes, glucose, lactate and oximetry in heparinized whole blood. The ABL90 FLEX 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.

pH, p02 and pC02: pH, pC02 and p02 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cK): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Sodium (cNa ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration. inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Calcium (cCa2'): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany,

Chloride (cCT): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Rute Chealer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K120197

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# Indications for Use

510(k) Number (if known): k120197

Device Name: ABL90 FLEX Analyzer

Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO>: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

Prescription Use X (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Rute Chaber

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 120197