(172 days)
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No
The document describes a standard automated analyzer for measuring blood parameters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The software validation mentioned relates to handling glucose results based on pO2 values, which is a rule-based logic, not AI/ML.
No.
The device is an in vitro diagnostic (IVD) analyzer used to measure various parameters in whole blood, such as glucose, pH, and oximetry parameters. Its intended use is for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." Additionally, it measures various parameters in whole blood (e.g., glucose, pH, pO2) which are used to aid in diagnosis.
No
The device description explicitly states that the analyzers consist of an instrument with a sensor cassette and a solution pack as the main accessories, indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Nature of Measurement: The device measures various parameters (glucose, pH, pO2, etc.) in whole blood, which is a biological sample taken from the body.
- Purpose of Measurement: The measurements are intended to provide information about a patient's health status, which is the core purpose of in vitro diagnostics.
- Setting of Use: The device is intended for use in laboratory, near patient, or point-of-care settings, which are typical environments for IVD devices.
N/A
Intended Use / Indications for Use
The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX 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. For in vitro diagnostic use.
The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, 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. For in vitro diagnostic use.
Product codes
CGA
Device Description
The names of the device are the ABL80 FLEX or ABL80 FLEX CO-OX. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA. Radiometer Medical ApS, Brønshøj, Denmark is the legal manufacturer of the device as specified in the labelling.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers are portable, automated systems intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, hematocrit (ABL80 FLEX analyzer only) and the oximetry parameters (ABL80 FLEX CO-OX only) total hemoqlobin, oxygen saturation, FO2Hb, FCOHb, FMetHb, and FHHb.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers each exist in two different software configurations differing in the number of parameters available.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers consist of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test loads are available. The solution pack is available in four model for each of the four different configurations of the analyzer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition", EP07-A2 to characterize the impact of, or interference from, limitations on the amounts of oxygen in the sample.
The test results support the glucose linearity ranges shown below and documented in the labeling:
| pO₂ (mmHg)range | cGlu mg/dL (mmol/L)linearity range |
|---|---|
| 20 - 40 | 36 – 180 (2 – 10) |
| ≥ 41 | 36 - 270 (2 – 15) |
Software validation has been conducted and documented for the ABL80 FLEX and ABL80 FLEX CO-OX analyzers to automatically handle certain glucose results depending on the pO2 value in the sample. This will allow to incorporate limitations of reporting glucose results when the pO₂ value of the sample is low.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 7, 2015
SENDX MEDICAL INC SOREN BOGESTRAND SENIOR REGULATORY AFFAIRS SPECIALIST AKANDEVEJ 21 BRONSHOJ 2700, DENMARK
Re: K151639
Trade/Device Name: ABL80 FLEX ABL80 FLEX CO-OX Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA Dated: November 04, 2015 Received: November 06, 2015
Dear Soren Bogestrand:
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 (OS) 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/ResourcesforYou/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,
Katherine Serrano -S
For: 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
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Indications for Use
510(k) Number (if known) K151639
Device Name ABL80 FLEX ABL80 FLEX CO-OX
Indications for Use (Describe)
The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX 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. For in vitro diagnostic use.
The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, 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. For in vitro diagnostic use.
| 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)
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510(k) Summary
1. Submitter and contact information
Submitter
| Company Name: | SenDx Medical Inc |
|---|---|
| ER Number: | 2027541 |
| Address: | 1945 Palomar Oaks Way |
| Carlsbad, CA 92011 | |
| USA | |
| Phone: | 760 930 6300 |
| Fax: | 760 930 6310 |
Contact Person
| Name: | Vibeke Agerlin, Director of QA/RA |
|---|---|
| Function: | Director of QA/RA |
| E-mail: | vagerlin@sendx.com |
| Phone: | 760 930 6300 |
| Fax: | 760 930 6310 |
Date prepared
| Date: | December 4, 2015 |
|---|---|
| ------- | ------------------ |
2. a. Device Information
| Device Name: | ABL80 FLEX and ABL80 FLEX CO-OX analyzer |
|---|---|
| Common Name: | Blood gases, Cooximetry, and Metabolite analyzer |
Classification :
| Classification name | CFR Section | Device Class | Product Code |
|---|---|---|---|
| Glucose oxidase, Glucose | 862.1345 | II | CGA |
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2. b. Device Description
Instrument name, manufacturer, models and accessories
The names of the device are the ABL80 FLEX or ABL80 FLEX CO-OX. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA. Radiometer Medical ApS, Brønshøj, Denmark is the legal manufacturer of the device as specified in the labelling.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers are portable, automated systems intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, hematocrit (ABL80 FLEX analyzer only) and the oximetry parameters (ABL80 FLEX CO-OX only) total hemoqlobin, oxygen saturation, FO2Hb, FCOHb, FMetHb, and FHHb.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers each exist in two different software configurations differing in the number of parameters available.
The ABL80 FLEX and ABL80 FLEX CO-OX analyzers consist of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test loads are available. The solution pack is available in four model for each of the four different configurations of the analyzer.
2. c. Purpose of submission
The purpose of this submission is twofold:
- Automated handling by the software of certain glucose results depending on the pO2 value . in the sample.
- To merge the Intended Uses for the analyzers into one common Intended Use statement.
3. Intended Use/Indications for use
The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX 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.
For in vitro diagnostic use.
The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, 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.
For in vitro diagnostic use.
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4. Predicate device: ABL800 FLEX analyzer (K043218) Substantial Equivalence
The modified ABL80 FLEX and ABL80 FLEX CO-OX analyzers are substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate with regards to glucose measurements:
Predicate device: 510(k) Number, Name, Device Manufacturer:
| Similarities | ||||
|---|---|---|---|---|
| Issue | SE Device | Predicate Device (K043218) | ||
| Product code | Same | CGA | ||
| Measuring method | Same | Amperometric | ||
| Calibration Method | Same | Two-point liquid calibration | ||
| Intended Use | The ABL80 FLEX and ABL80 FLEX | |||
| CO-OX analyzers are portable, | ||||
| automated analyzers that | ||||
| measure glucose in whole blood. | Same, plus the following parameters | |||
| pH, pO₂, pCO₂, potassium, sodium, | ||||
| calcium, chloride, glucose, lactate, | ||||
| total bilirubin, and co-oximetry | ||||
| parameters (total hemoglobin, | ||||
| oxygen saturation, and the | ||||
| hemoglobin fractions FO2Hb, FCOHb, | ||||
| FMetHb, FHHb and FHbF) | ||||
| Glucose measuring | ||||
| range | 36-180 mg/dL (pO2 between 20 - | |||
| 40 mmHq); | ||||
| 36-270 mg/dL (pO2 ≥ 41 mmHq) | 36-270 mg/dL |
1 0 חחק ומח C
| Differences | ||
|---|---|---|
| Issue | SE Device | Predicate Device (K043218) |
| Intended use site | Laboratory and point-of-care. | Laboratory. |
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5. Performance Characteristics
Glucose p02 dependence
A study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition", EP07-A2 to characterize the impact of, or interference from, limitations on the amounts of oxygen in the sample.
The test results support the glucose linearity ranges shown below and documented in the labeling:
| Glucose linearity versus pO₂ level | |
|---|---|
| pO₂ (mmHg) | |
| range | cGlu mg/dL (mmol/L) |
| linearity range | |
| 20 - 40 | 36 – 180 (2 – 10) |
| ≥ 41 | 36 - 270 (2 – 15) |
Software validation has been conducted and documented for the ABL80 FLEX and ABL80 FLEX CO-OX analyzers to automatically handle certain glucose results depending on the pO2 value in the sample. This will allow to incorporate limitations of reporting glucose results when the pO₂ value of the sample is low.
6. Conclusion
Based on the substantial equivalence comparison and the results of the conducted performance evaluations it has been concluded that the modified ABL80 FLEX and ABL80 FLEX CO-OX analyzers are as safe and effective as the predicate device.