ABL90 FLEX

K122642 · Radiometer Medical Aps · CHL · Oct 26, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122642
• Device Name: ABL90 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Oct 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended 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. pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium (cKT): 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 (cCart): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride (cCI¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis. 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. sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoqlobin. 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.

Device Story

ABL90 FLEX is a portable, automated analyzer for in vitro testing of heparinized whole blood. Inputs: whole blood samples. Principle: potentiometry for pH, blood gases (pO2, pCO2), and electrolytes (K+, Na+, Ca2+, Cl-); amperometry for metabolites (glucose, lactate); spectrophotometry for oximetry (total hemoglobin, oxygen saturation, hemoglobin fractions). Operation: aspiration of sample; menu-driven touch screen interface. Used in laboratory or point-of-care settings by trained clinicians. Output: quantitative measurement of blood parameters. Clinical utility: aids diagnosis/treatment of acid-base disturbances, electrolyte disorders, metabolic conditions, anemia, and carbon monoxide poisoning. Modification: addition of WiFi for wireless network connectivity, supplementing existing wired LAN.

Clinical Evidence

No clinical data; bench testing only. Performance characteristics are unaffected by the WiFi modification; original performance data from K092686 remains applicable.

Technological Characteristics

Portable, automated analyzer. Sensing: potentiometry (pH, gases, electrolytes), amperometry (metabolites), spectrophotometry (oximetry). Power: 230/120 V mains. Connectivity: wired LAN and wireless LAN. Operating system: Windows XP Embedded. Form factor: touch screen interface, aspiration-based sample introduction.

Indications for Use

Indicated for use by trained technologists, nurses, physicians, and therapists in laboratory or point-of-care settings for the analysis of heparinized whole blood to diagnose and treat acid-base disturbances, electrolyte imbalances, carbohydrate metabolism disorders (e.g., diabetes), lactic acidosis, anemia, and carbon monoxide poisoning.

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 (K092686)

Submission Summary (Full Text)

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Special 510(k): Device Modification to ABL90 Flex - WiFi

RADIOMETER ®

K122642

# Section 5. 510(k) Summary

OCT 2 6 2012

## 1. Administrative

| Device Information | |
|-----------------------|-------------------------------------------------------------|
| Device Name: | ABL90 Flex |
| Common Name: | Blood gases and blood pH test system |
| Product Code: | CHL (JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX) |
| Registration Number: | 21 CFR 862.1120 |
| Classification: | Class II |
| Classification Panel: | Clinical Chemistry |
| Submitter | |

| Company Name: | Radiometer Medical ApS |
|---------------|----------------------------------------------|
| ER Number: | 3002807968 |
| Address: | Aakandevej 21<br>2700 Broenshoej<br>Denkmark |
| Phone: | [phone] |
| Fax: | [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, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).

The implementation of the WiFi option allows wireless functionality for establishing network connectivity; all of which is supported by wired LAN connection in the existing application.

### 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 implementation of the WiFi option 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 (subsequent submissions: K111897, K120197)

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# Special 510(k): Device Modification to ABL90 Flex - WiFi

RADIOMETER IR

| Predicate: ABL90 Flex (K092682) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Wireless LAN network connectivity utilizing<br>standard technology and protocols provided<br>and supported by the operating system<br>(Windows XP Embedded). Currently this is<br>provided by establishing cabled LAN<br>connections. |
| Blood Gas Measurement | |
| pH, pO₂, pCO₂ by potentiometry | |
| Electrolyte Measurement | |
| cK⁺, cNa⁺, cCa²⁺, cCl⁻ by potentiometry | |
| Metabolite Measurement | |
| cGlu, cLac by amperometry | |
| Oximetry Measurement | |
| ctHb, sO₂ FO₂Hb, FHHb, FCOHb, FMetHb,<br>FHbF | |
| Hemoglobin Measurement | |
| Spectrophotometry | |
| Identical Performance Characteristics | |
| Two-Point liquid calibration | |
| Menu driven touch screen | |
| Software operating system | |
| Microsoft XPE | |
| Sample Introduction | |
| Aspiration | |
| Dimensions (length x width x depth) | |
| External Power Source | |
| 230/120 V mains | |

# 5. Performance Data

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

### 6. Conclusion

The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientific technology, and characteristics to the predicate ABL90 Flex. For the implementation of the change design control principles (risk management, verification, validation) have been applied which indicated that the change is of no impact to the performance of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

10903 New Hampshire Avenue Silver Spring, MD 20993

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

OCT 26 2012

Re: k122642

> Trade Name: ABL90 Flex Analyzer 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, KHP, KQI, JJY Dated: October 1, 2012 Received: October 3, 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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# Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you dealle specific at hitro Diagnostic Devices and Radiological Health 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 (21 CFA Part 001197) 1 or Galleric's (OSB's) Division of Postmarket Surveillance at (301) Office of Dal valiano and Drolling of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

OFF it For 805), preace aroblem/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 r ou may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or [phone] or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

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

Enclosure

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# Indications for Use

510(k) Number (if known): k122642

Device Name: ABL90 Flex Analyzer

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.

pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cKT): 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 (cCart): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Chloride (cCI¯): 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 (OIR)

Bustle Ch

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

510(k) &(2.2642

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# Indications for Use

510(k) Number (if known): k122642

Device Name: ABL90 Flex Analyzer

Indications For Use:

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.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoqlobin.

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.

And/Or Over the Counter Use Prescription Use X (21 CFR Part 801 Subpart D) (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 (OIR)

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

K122642 510(k)

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