(29 days)
No
The document describes standard analytical methods (potentiometry, amperometry, conductometry, spectrophotometry) and data management integration. There is no mention of AI or ML algorithms being used for analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) device used for measuring various analytes in whole blood to aid in the diagnosis and treatment of diseases, rather than directly providing therapy.
Yes
The device measures various physiological parameters (pH, blood gases, electrolytes, glucose, oximetry) in whole blood, which are explicitly stated to be "used in the diagnosis and treatment of life-threatening acidbase disturbances," "diagnosis and treatment of aldosteronism, diabetes insipidus," and "diagnosis and treatment of carbohydrate metabolism disorders," among others. This directly indicates its use for diagnostic purposes.
No
The device is a blood gas analyzer which is a hardware device that uses various measuring principles (potentiometry, amperometry, conductometry, spectrophotometry) to analyze blood samples. While it includes software for data management and connectivity, the core functionality is based on physical measurements performed by the hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood." These are measurements performed on biological samples (whole blood) to provide information about a patient's health status.
- Indications for Use: The indications for use list specific clinical conditions and purposes for which these measurements are used in diagnosis and treatment (e.g., "diagnosis and treatment of life-threatening acidbase disturbances," "monitor electrolyte balance in the diagnosis and treatment of disease conditions," "aid in the diagnosis of carbon monoxide poisoning"). This clearly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device description states it is "intended for in vitro testing of samples of whole blood." "In vitro" means "in glass" or "in the laboratory," referring to tests performed outside of the living organism.
- Measuring Principles: The measuring principles described (Potentiometry, Amperometry, Conductometry, Spectrophotometry) are all methods used to analyze the chemical and physical properties of biological samples.
Therefore, based on the provided information, the ABL80 FLEX CO-OX analyzer fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use:
The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood. The ABL80 FLEX CO-OX analyzer system 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.
Indications for use:
These tests are only performed under a physicians order:
pH, pO2.and pCO2 . pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase 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 (cCl-): 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, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. 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 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.
Product codes (comma separated list FDA assigned to the subject device)
CHL, JGS, CEM, JFP, CGZ, CGA, GKR, DQA, GHS, JPI
Device Description
The ABL80 FLEX CO-OX with AQURE connectivity is a portable, automated system intended for in vitro testing of samples of whole blood. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA.
ABL80 FLEX CO-OX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes and solution packs are available. The various sensor cassette models include models for the different parameter configurations.
Four measuring principles are employed in ABL80 FLEX analyzers.
- Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related ● to the concentration of the sample (the Nernst equation).
- . Amperometry: The magnitude of an electrical current flowing through a sensor chain is proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain.
- . Conductometry: Specific impedance of a sample as measured by two conducting electrodes held at a constant voltage is directly proportional to the conductive properties of that sample.
- . Spectrophotometry: Light passes through a cuvette containing a hemolyzed blood sample. The specific wavelengths absorbed and their intensity generates an absorption spectrum used to calculate oximetry parameters. This measuring principle is used in the ABL80 FLEX CO-OX analyzer only.
The modification consists of integration with the Data Management software called AQURE system. The software enables the initiation of device actions on connected ABL80 FLEX analyzers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Remote functionality was verified and validated on both ABL80 FLEX and ABL80 FLEX CO-OX analyzers, and the acceptance criteria was met.
No performance characteristics are affected by the change. The performance data submitted in the original submission (K051804 as modified by K080370) still apply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
SENDX MEDICAL INC. LASSE MOLLER REGULATORY AFFAIRS SPECIALIST AAKANDEVEJ 21 BROENSHOEJ 2700 DENMARK
Re: K151856
Trade/Device Name: ABL80 FLEX CO-OX with AQURE Connectivity Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, GKR, DQA, GHS, JPI Dated: July 3, 2015 Received: July 8, 2015
Dear Lasse Moller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151856
Device Name ABL80 FLEX CO-OX with AQURE connectivity
Indications for Use (Describe)
Intended Use:
The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood. The ABL80 FLEX CO-OX analyzer system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-ofcare setting.
Indications for use:
These tests are only performed under a physicians order:
pH, pO2.and pCO2 . pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase 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 (cCl-): 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, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. 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 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Date Prepared: August 5, 2015
Section 5. 510(k) Summary
1. Administrative
Submitter
| Company Name: | SenDx Medical Inc |
|---|---|
| ER Number: | 2027541 |
| Address: | 1945 Palomar Oaks Way |
| Carlsbad, CA 92011 | |
| USA | |
| Contact Person: | Vibeke Agerlin, Director of QA/RA |
| Phone: | +1 760 930 6300 |
| Fax: | +1 760 930 6310 |
Application Correspondent
| Name: | Lasse Post Møller |
|---|---|
| Function: | Regulatory Affairs Specialist |
| E-mail: | lpm@radiometer.dk |
| Phone: | +45 3827 3436 |
| Fax: | +45 3827 2727 |
2. Device description
Device Information
| Device Name: | ABL80 FLEX CO-OX with AQURE connectivity |
|---|---|
| Common Name: | Blood gas analyzer |
| Product Code: | CHL (JGS, CEM, JFP, CGZ, CGA, GKR, DQA, GHS, JPI) |
| Code description: | Blood gases and blood pH test system |
| Regulation Number: | 21 CFR 862.1120 |
| Classification: | Class II |
| Classification Panel: | Clinical Chemistry |
The ABL80 FLEX CO-OX with AQURE connectivity is a portable, automated system intended for in vitro testing of samples of whole blood. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA.
ABL80 FLEX CO-OX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes and solution packs are available. The various sensor cassette models include models for the different parameter configurations.
5
Four measuring principles are employed in ABL80 FLEX analyzers.
- Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related ● to the concentration of the sample (the Nernst equation).
- . Amperometry: The magnitude of an electrical current flowing through a sensor chain is proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain.
- . Conductometry: Specific impedance of a sample as measured by two conducting electrodes held at a constant voltage is directly proportional to the conductive properties of that sample.
- . Spectrophotometry: Light passes through a cuvette containing a hemolyzed blood sample. The specific wavelengths absorbed and their intensity generates an absorption spectrum used to calculate oximetry parameters. This measuring principle is used in the ABL80 FLEX CO-OX analyzer only.
3. Device Modification
The modification consists of integration with the Data Management software called AQURE system. The software enables the initiation of device actions on connected ABL80 FLEX analyzers.
4. Intended Use
The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood. The ABL80 FLEX CO-OX analyzer system 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.
Indications for use:
These tests are only performed under a physicians 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 diaqnosis 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, neonatal hypoqlycemia, and idiopathic hypoqlycemia, and of pancreatic islet cell carcinoma.
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 oxyhemoqlobin plus reduced hemoqlobin.
FO2Hb: oxyhemoqlobin as a fraction of total hemoqlobin
6
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.
5. Substantial Equivalence
The modified ABL80 FLEX CO-OX analyzer is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate (K080370).
7
| Similarities | ||
|---|---|---|
| Issue | SE Device | Predicate Device |
| (K080370) | ||
| Intended Use | Same | The ABL80 FLEX CO-OX analyzer is a portable, |
| automated analyzer that measures pH, blood gases, | ||
| electrolytes, glucose, and oximetry in whole blood. The | ||
| ABL80 FLEX CO-OX analyzer system 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. | ||
| Blood Gas | ||
| Measurement | Same | pH, pCO2 by potentiometry, |
| pO2 by amperometry | ||
| Electrolyte | ||
| Measurement | Same | cK+, cNa+, cCa2+, cCl- by potentiometry |
| Metabolite | ||
| Measurement | Same | cGlu by amperometry |
| Oximetry | ||
| Measurement | Same | ctHb, sO2, FO2Hb, FHHb, FCOHb, FMetHb by |
| spectrophotometry | ||
| Performance | ||
| Characteristics | Same | Identical Performance Characteristics |
| Calibration | Same | Two-Point liquid calibration at configured intervals, tHb |
| calibration every 90 days | ||
| Computer | ||
| specifications | Same | Microsoft Windows®XP Embedded operating system |
| Minimum 1 GB hard drive | ||
| ETX single board CPU | ||
| Minimum 512 MB EDO-RAM | ||
| Sample Introduction | Same | Aspiration |
| Interfaces | Same | 8.4" color TFT-LCD, resolution 800 × 600 SVGA Touch |
| screen, Barcode reader, Serial line RS232, RJ45, | ||
| Ethernet port, 2 USB 1.1, PS2 keyboard | ||
| Software version | Same | Software version 3.12 |
8
| Differences | ||
|---|---|---|
| Issue | SE Device | Predicate Device |
| (K080370) | ||
| AQURE system | Data management software (MDDS) functionality: | |
| Remote display of test results Receival of data from connected devices at the point-of-care or laboratory Transfer of test results to the HIS/LIS Centralized operator administration – Transmission of operator data to ABL80 FLEX CO-OX Remote approval of patient results | Analyzer functionalities are: | |
| Local display of test results Direct transfer of test results to the HIS/LIS Local Operator Administration at the analyzer | ||
| Remote initiation of the following device actions on ABL80 FLEX CO-OX from AQURE system: | ||
| System Cycle Rinse Lock/Unlock analyzer Lock/Unlock parameter Set analyzer message Enter/Exit standby 2 point calibration | Local initiation of device actions through device touch screen interface |
6. Registration history
ABL80 FLEX was originally cleared with K051804 (measures pH, blood gases, electrolytes, glucose, hematocrit (ABL80 FLEX analyzer only), and then modified in K080370 with the addition of an oximetry Module - a configuration of the analyzer adding the oximetry parameters ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, and FHHb.
7. Performance Data
Remote functionality was verified and validated on both ABL80 FLEX and ABL80 FLEX CO-OX analyzers, and the acceptance criteria was met.
No performance characteristics are affected by the change. The performance data submitted in the original submission (K051804 as modified by K080370) still apply.
8. Summary of Design Control activities
9
We conducted an FMEA risk analysis and mitigated all identified hazards to an acceptable level as per ISO 14971, and verified software mitigations by using test protocols. Results met predefined acceptance criteria.
9. Conclusion
The ABL80 FLEX CO-OX with AQURE connectivity described above is substantially equivalent in Intended Use, fundamental scientific technology, safety, effectiveness and characteristics to the predicate ABL80 Flex CO-0X (K080370). Implementation of the change design control principles (risk management, verification and validation) have been applied which indicated that the modification is of no impact to the performance of the device.