(14 days)
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.
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.
This 510(k) notification describes a modification to an existing device, the ABL90 Flex analyzer. The modification involves equipping the analyzer with rechargeable batteries and updating the software to control battery charging and display status. Because the modification does not affect the performance characteristics of the device, the submission references performance data from the predicate device (K092686) rather than providing new performance data for the modified device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Acceptance Criteria | Reported Device Performance | Study Details |
|---|---|---|
| Intended Use | Substantially equivalent to ABL90 Flex (K092686) | The modified ABL90 Flex retains the same intended use: portable, automated analyzer for pH, blood gases, electrolytes, glucose, lactate, and oximetry in whole blood, for use by trained personnel in laboratory, near-patient, or point-of-care settings. The added battery option does not alter the fundamental purpose or application of the device. |
| Blood Gas Measurement (pH, pO2, pCO2) | Identical Performance Characteristics to ABL90 Flex (K092686) | The submission explicitly states "No performance characteristics are affected by the change. The performance data submitted in K092686 still apply." This implies that the performance of the modified device for blood gas measurements meets the same acceptance criteria as the predicate. |
| Electrolyte Measurement (cK+, cNa+, cCa2+, cCl-) | Identical Performance Characteristics to ABL90 Flex (K092686) | Same as above. The battery modification does not impact the electrochemical sensing capabilities. |
| Metabolite Measurement (cGlu, cLac) | Identical Performance Characteristics to ABL90 Flex (K092686) | Same as above. The battery modification does not impact the amperometric sensing capabilities. |
| Oximetry Measurement (ctHb, sO2 FO2Hb, FHHb, FCOHb, FMetHb, FHbF) | Identical Performance Characteristics to ABL90 Flex (K092686) | Same as above. The battery modification does not impact the spectrophotometric sensing capabilities. |
| Hemoglobin Measurement (Spectrophotometry) | Identical Performance Characteristics to ABL90 Flex (K092686) | Same as above. The battery modification does not impact the spectrophotometric sensing capabilities. |
| Two-Point Liquid Calibration | Identical Performance Characteristics to ABL90 Flex (K092686) | Same as above. Calibration procedures are not affected. |
| Menu-Driven Touch Screen | Identical Performance Characteristics to ABL90 Flex (K092686) | Same as above. The user interface remains consistent, with additional battery-related indicators. |
| Software Operating System (Microsoft XPE) | Identical Performance Characteristics to ABL90 Flex (K092686) | The core operating system remains the same, with minor updates to control battery functions. |
| Sample Introduction (Aspiration) | Identical Performance Characteristics to ABL90 Flex (K092686) | The sample handling mechanism is unchanged. |
| Dimensions (length x width x depth) | Increased by approx. 600g compared to ABL90 Flex (K092686) | While the dimensions are noted as a similarity, the weight is explicitly a difference. This is a physical characteristic, not a performance characteristic related to the analytical capabilities. |
| External Power Source (230/120 V mains) | Identical Performance Characteristics to ABL90 Flex (K092686) | The device can still operate via external power, the battery is an additional option. |
Study that Proves the Device Meets Acceptance Criteria:
The core statement is: "No performance characteristics are affected by the change. The performance data submitted in K092686 still apply." This means the predicate device's (ABL90 Flex, K092686) performance studies are relied upon to demonstrate equivalence. The K111897 submission itself does not detail new performance studies beyond confirming that the addition of a battery and software updates did not degrade existing performance.
The study proving the device (as modified) meets acceptance criteria is implicitly the study (or studies) associated with the original 510(k) for the ABL90 Flex (K092686). This current submission for the ABL90 Flex with the Battery Option (K111897) is a "Special 510(k): Device Modification" which attests that the changes do not affect safety or effectiveness, therefore, the original performance data is still valid.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided text for the K111897 submission. The submission relies on the original K092686 data.
- Data Provenance: Not explicitly stated in the provided text for the K111897 submission. For the original K092686 device, this information would have been in its 510(k) submission. However, the manufacturer is Radiometer Medical ApS, based in Denkmark.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated in the provided text for the K111897 submission.
- Qualifications of Experts: Not explicitly stated in the provided text for the K111897 submission.
As this is a "Special 510(k)" for a minor modification, these details about the ground truth establishment for the test set would be found in the original K092686 submission, as the analytical performance itself is not being re-evaluated for the battery modification. For in-vitro diagnostic devices measuring biomarkers like these, clinical performance often involves comparison against a reference method using patient samples or control materials.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not explicitly stated. The provided information pertains to an in-vitro diagnostic device that measures specific analytes. The "test set" for such devices typically involves running known samples (calibrators, controls, patient samples already characterized by a reference method) and comparing the device's numerical output against established values or a reference method, rather than involving subjective interpretation requiring adjudication among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, not applicable. This type of study is primarily relevant for imaging devices or other diagnostic tools where human interpretation of data (e.g., medical images) is involved. The ABL90 Flex is an automated analyzer providing quantitative measurements, not requiring human readers for core diagnostic interpretation in the same way an imaging system would.
6. Standalone Performance Study
- Standalone Performance Study: Yes (implicitly). The device itself (the ABL90 Flex, originally cleared under K092686) undergoes standalone performance testing to validate its analytical capabilities (accuracy, precision, linearity, interference, etc.) for each measured parameter. The current submission (K111897) states that its "Identical Performance Characteristics" validate that the addition of the battery does not alter this standalone performance. Thus, the original standalone performance of the ABL90 Flex is being relied upon.
7. Type of Ground Truth Used
-
Type of Ground Truth: The ground truth for such an in-vitro diagnostic device typically involves:
- Reference Methods: Comparison of device measurements against established, highly accurate reference methods for each analyte (e.g., gas chromatography-mass spectrometry for some blood gases, atomic absorption spectroscopy for electrolytes, enzymatic methods for glucose/lactate).
- Certified Reference Materials/Controls: Use of materials with known, certified concentrations of the analytes.
- Clinical Correlation (for some parameters): For certain parameters like pH, pO2, pCO2, clinical relevance is established by showing correlation with patient clinical status, but the primary analytical ground truth is usually a reference measurement method.
The K111897 submission does not detail this, but K092686 certainly would have.
8. Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated in the provided text. For an IVD, "training set" might refer to data used for algorithm development within the device (e.g., calibration curves, correction factors). If machine learning was used for any part of the analytical process, this would be described in the original 510(k) (K092686), but the primary functions of this device (potentiometry, amperometry, spectrophotometry) are based on established physiochemical principles rather than complex machine learning algorithms requiring large training sets in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not explicitly stated. Similar to point 8, if specific "training" data was used for internal algorithms, the ground truth would be established using reference methods, calibrators, and control materials as part of the device's development and validation process during the original K092686 submission.
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RADIOMETER IR
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 212700 BroenshoejDenkmark |
| Phone: | +45 3827 3827 |
| Fax: | Fax: +45 3827 2727 |
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 UseThe ABL90 FLEX is a portable, automatedanalyzer that measures pH, blood gases,electrolytes, glucose, lactate and oximetry inwhole blood. The ABL90 FLEX is intended foruse by trained technologists, nurses,physicians and therapists. It is intended foruse in a laboratory environment, near patientor point-of-care setting. | Internal Power SourceBattery Pack with charger unitInput: 24 Vdc, 48WOutput: 24Vdc, 2250mAh |
| Blood Gas MeasurementpH, pO₂, pCO₂ by potentiometry | Light Emitting Diodes (green and yellow) inanalyzer socket |
| Electrolyte MeasurementcK⁺, cNa⁺, cCa²⁺, cCl⁻ by potentiometry | Battery status and charging symbols onanalyzer screen |
| Metabolite MeasurementcGlu, cLac by amperometry | Increased by ca. 600g compared to ABL90Flex (K092686) |
| Oximetry MeasurementctHb, sO₂ FO₂Hb, FHHb, FCOHb, FMetHb,FHbF | |
| Hemoglobin MeasurementSpectrophotometry | |
| Identical Performance Characteristics | |
| Two-Point liquid calibration | |
| Menu driven touch screen | |
| Software operating systemMicrosoft XPE | |
| Sample IntroductionAspiration | |
| Dimensions (length x width x depth) | |
| External Power Source230/120 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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Page 2 -
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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 UseX (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-CounterUse (21 CFR801 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)
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 UseX(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-CounterUse________(21 CFR801 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
Page 2 of 2.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.