ABL90

K111897 · Radiometer Medical Aps · CHL · Jul 19, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111897
• Device Name: ABL90
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jul 19, 2011
• 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 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, pO2 and pCO2 : pH, pCO2 and pO2 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 (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 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.

Device Story

Portable, automated blood gas analyzer for point-of-care or laboratory use. Analyzes heparinized whole blood samples via aspiration. Measures pH, pO2, pCO2, electrolytes (K+, Na+, Ca2+, Cl-), metabolites (glucose, lactate), and oximetry parameters (total hemoglobin, oxygen saturation, hemoglobin fractions) using potentiometry, amperometry, and spectrophotometry. Modification adds rechargeable battery pack and charging status indicators (LEDs/screen symbols). Operated by trained technologists, nurses, physicians, or therapists. Output displayed on touch screen to assist clinical decision-making for life-threatening conditions and metabolic disorders.

Clinical Evidence

No clinical data provided. Performance characteristics are unchanged from the predicate device (K092686); bench testing only.

Technological Characteristics

Portable, automated analyzer. Measurement principles: potentiometry (pH, blood gases, electrolytes), amperometry (glucose, lactate), and spectrophotometry (hemoglobin). Power: 24 Vdc, 48W input; 24Vdc, 2250mAh output. Interface: menu-driven touch screen with LED status indicators. Software: Microsoft XPE operating system.

Indications for Use

Indicated for patients requiring blood gas, electrolyte, metabolite, and oximetry analysis in heparinized whole blood. Used by clinicians for diagnosis/treatment of acid-base disturbances, electrolyte imbalances, metabolic disorders (e.g., diabetes, cystic fibrosis), anemia, and carbon monoxide poisoning. Prescription use only.

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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RADIOMETER IR

K111897

# Section 5. 510(k) Summary

## 1. Administrative

JUL 19 2011

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: | 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, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF),

The existing ABL90 Flex analyzer has been equipped with rechargeable batteries and the analyzer software has been updated to control the charging of the battery and to provide indication regarding the charging status and level.

### 3. Intended Use

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

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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>whole blood. The ABL90 FLEX is intended for<br>use by trained technologists, nurses,<br>physicians and therapists. It is intended for<br>use in a laboratory environment, near patient<br>or point-of-care setting. | Internal Power Source<br>Battery Pack with charger unit<br>Input: 24 Vdc, 48W<br>Output: 24Vdc, 2250mAh |
| Blood Gas Measurement<br>pH, pO₂, pCO₂ by potentiometry | Light Emitting Diodes (green and yellow) in<br>analyzer socket |
| Electrolyte Measurement<br>cK⁺, cNa⁺, cCa²⁺, cCl⁻ by potentiometry | Battery status and charging symbols on<br>analyzer screen |
| Metabolite Measurement<br>cGlu, cLac by amperometry | Increased by ca. 600g compared to ABL90<br>Flex (K092686) |
| Oximetry Measurement<br>ctHb, sO₂ FO₂Hb, FHHb, FCOHb, FMetHb,<br>FHbF | |
| Hemoglobin Measurement<br>Spectrophotometry | |
| Identical Performance Characteristics | |
| 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Radiometer Medical Aps c/o Martin Gabler Aakandevej 21, Copenhagen, 2100 DA - DENMARK

JUL 1 9 2011

Re: k111897

Trade/Device Name: ABL90 Flex Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system. Regulatory Class: II Regulatory Class. II
Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Dated: June 29, 2011 Received: July 5, 2011

Dear: Mr. Gabler:

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 310(x) promatine device is substantially equivalent (for device felefenced above and have actestionire) to legally marketed predicate devices
the indications for use stated in the enclosure, on 1976, the spectment date of the the indications for use station in the encreases, 2076, the enatment date of the marketed in interstate commerce prior to have been reclassified in accordance Medical Device Alliendinents, of to Govenetic Act (Act) that do not require
with the provisions of the Federal Food, Drug, and Cosmer, therefore, market the with the provisions of the Federal Pood, Brag, and . You may, therefore, market the approval of a premarker approval approvalions of the Act. The general controls device, subject to the general controls provision and registration, listing of devices, good
provisions of the Act include requirements for annual registration, provisions of the Act filende requirements for unlabiling and adulteration.
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 If your device is classified (See above) into controls. Existing major regulations (CFF (PMA), it may be subject to such additional of Federal Regulations (CFR), Parts affecting your device can be found in This 21, Courselves of Concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does Please be advised that FDA s issuance of a substions administered by other not mean that FDA has made a deterniniation and regulations administered by other requirements of the Act of any Pecolar states requirements, including, but not
Federal agencies. You must comply with all the Act's requirements, including (21 CER Parts 80 Federal agencies: "Tourmust compry with and 1077; labeling (21 CFR Parts 801 and 809); medical device reporting (21 CFR Parts of medical device events) (21 809); medical device reporting (teporting or mosted in the quality in the quality
CFR 803); and good manufacturing practice requirements as set forth in the quality
2007); an 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 Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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/cdrh/industry/support/index.html.

Sincerely yours,

CJC.

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

: VY: :

Enclosure

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Special 510(k): Device Modification to ABL90 Flex

Image /page/4/Picture/1 description: The image shows the word "RADIOMETER" in bold, black letters. To the right of the word is a registered trademark symbol, which is a capital "R" inside of a circle. The text is simple and clear, with a focus on the brand name.

# Section 4. Indications for Use

510(k) Number (if known): K ||| 897 Device Name: ABL90 Flex Analyzer

> 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, pO2 and pCO2 : pH, pCO2 and pO2 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 (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.

| Indications for Use: Prescription Use<br>X (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter<br>Use (21 CFR<br>801 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

C

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) ic 111 & 4

ge 1 of 2

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# Section 4, Indications for Use

510(k) Number (if known): __ Device Name: ABL90 Flex Analyzer

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 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.

| Indications for Use: Prescription Use<br>_X_(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter<br>Use________(21 CFR<br>801 Subpart C) |
|-------------------------------------------------------------------------|--------|----------------------------------------------------------|
|-------------------------------------------------------------------------|--------|----------------------------------------------------------|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

H. Miller & Co.

Division Sign-Off Office of In Vitro Diagnostic Device Fyaluation and Safety 510(k) K // 2

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