(170 days)
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No
The document describes a standard automated analyzer with sensors, a spectrometer, and "smart chip" technology for identification and calibration data. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities.
No
The device is an analyzer that measures various parameters in whole blood for diagnostic purposes, not for treating diseases or conditions.
Yes
The device measures various blood parameters (e.g., pH, blood gases, electrolytes, glucose, oximetry) that are explicitly stated to be "used in the diagnosis and treatment of life-threatening acid-base disturbances" or "used in the diagnosis and treatment of disease conditions." These are direct uses in diagnosing medical conditions.
No
The device description clearly outlines hardware components including a modular analyzer, user interface module, sensors, oximetry module, and reagent cartridge. It is a physical device that performs measurements.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is explicitly described as measuring various analytes (pH, blood gases, electrolytes, glucose, oximetry) in whole blood. This is a biological specimen taken from the human body.
- Purpose: The measurements are used in the diagnosis and treatment of various disease conditions and imbalances (acid-base disturbances, electrolyte imbalances, carbohydrate metabolism disorders, carbon monoxide poisoning, anemia). This aligns directly with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The description details the components that perform the analysis of the blood sample (sensors, oximetry module, reagent cartridge).
The fact that it measures analytes in a human biological specimen (whole blood) for diagnostic and treatment purposes clearly places it within the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX 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.
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, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The following six parameters will be introduced with the ABL80 FLEX CO-OX:
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sOx 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.
Product codes (comma separated list FDA assigned to the subject device)
75CHL, 75JGS, 75CEM, 75JFP, 75CGZ, 75CGA, 75GKR, 75DQA, 75GHS, GKR, GHS, GLY, JJY, CHL, JGS, CEM, JFP, CGZ, CGA
Device Description
The ABL80 FLEX CO-OX syste:n consists óf a modular analy.cer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidis modules. The user interface module contains the analyzer CP1J and all of the required electronic interfaces for external communication and data stor:ge.
Sensors that measure pH, pCO2, pO2, cCa2', cCI, cK* cNa* and cGlu are contained in a cassette that also contains the sample inlet. This cassette attaches to the front of the analyzer.
The oximetry module measures ctHb, sO2, FO2Hb, F MetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the analyzer.
The system also includes a reagent cartridge for the calibration and automatic quality control of the sensor and oximetry system. The calibration and quality control reagents are packaged in sealed foil pouches.
The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration and quality control data.
Mentions image processing
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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
The ABL80 FLEX CO-OX 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.
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)
The ABL700 will be used for the following data:
- Method Comparison: A.
- B. Precision
- Linearity/Assay Reportable Range C.
- D. Calibration/Quality Control
- E. Analytical specificity - Interference
- F. User Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for SENDX MEDICAL, INC. The logo is in black and white and features a stylized font. Below the company name is the text "A RADIOMETER COMPANY" in a smaller font.
RADIOMETER
Section III - 510(k) Summary of Safety and Effectiveness
| 1. SUBMITTER INFORMATION | JUL 31 2008 | ||
|---|---|---|---|
| A. | Establishment Registration: | 2027541 | |
| B. | Manufacturing Site: | SenDx Medical, Inc. | |
| C. | Company Address: | 1945 Palomar Oaks Way | |
| Carlsbad, CA 92011 | |||
| D. | Date Prepared: | February 5, 2008 | |
| 2. CONTACT PERSON | |||
| A. | Mark A. Dzendzel: | Manager, Regulatory Affairs and | |
| Quality Systems | |||
| B. | Phone: | 760-603-3412 | |
| C. | Fax: | 760-900-6310 | |
| D. | Email: | mdzendzel@sendx.com | |
| 3. DEVICE IDENTIFICATION | |||
| A. | Trade/Proprietary Name: | ABL80 FLEX CO-OX | |
| B. | Classification: | Class II (21CFR § 862.1120) | |
| C. | Product Code: | 75CHL | |
| D. | Subsequent Codes: | 75JGS 75CEM, 75JFP, 75CGZ, | |
| 75CGA, 75GKR, 75DQA, 75GHS |
4. DEVICE DESCRIPTION
The ABL80 FLEX CO-OX syste:n consists òf a modular analy.cer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidis modules. The user interface module contains the analyzer CP1J and all of the required electronic interfaces for external communication and data stor:ge.
Sensors that measure pH, pCO2, pO2, cCa2', cCI, cK* cNa* and cGlu are contained in a cassette that also contains the sample inlet. This cassette attaches to the front of the analyzer.
The oximetry module measures ctHb, sO2, FO2Hb, F MetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the analyzer.
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1
The system also includes a reagent cartridge for the calibration and automatic quality control of the sensor and oximetry system. The calibration and quality control reagents are packaged in sealed foil pouches.
The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration and quality control data.
5. INTENDED USE / INDICATIONS FOR USE
The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX 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.
SUBSTANTIAL EQUIVALENCE 6.
The ABL80 FLEX CO-OX is substantially equivalent in features and characteristics to the predicate ABL80 FLEX and the ABL700.
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K051804 | ABL80 FLEX | SenDx Medical, Inc. |
| K980130 | ABL700 Series | Radiometer Medical ApS |
With each of the listed devices and the ABL80 FLEX CO-OX, the principles of operation are similar;
| • Amperometry | pO₂, Glucose |
|---|---|
| --------------- | -------------- |
- pH, cNa*, cK*, cCa2+, cCl~, pCO2 . Potentiometry
- . Spectrophotometry ctHb, sO2, FO2Hb, FCOHb, FMetHb and FHHb
7. PERFORMANCE DATA
The ABL700 will be used for the following data:
- Method Comparison: A.
- B. Precision
- Linearity/Assay Reportable Range C.
- D. Calibration/Quality Control
- E. Analytical specificity - Interference
- F. User Testing
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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 eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SenDx Medical, Inc. c/o Mr. Mark A. Dzendzel Manager Regulatory Affairs & Quality Systems 1945 Palomar Oaks Way Carlsbad, CA 92011
JUL 3 1 2008
K080370 Trade Name: ABL80 Flex Co-Ox Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Codes: GKR, GHS, GLY, JJY, CHL, JGS, CEM, JFP, CGZ, CGA Dated: June 16, 2008 Received: June 20, 2008
Dear Mr. Dzendzel:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial squivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permitte your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please nothe the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080370
Device Name: ABL80 FLEX CO-OX
Indications for Use:
The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX 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.
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, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The following six parameters will be introduced with the ABL80 FLEX CO-OX:
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sOx oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) 2090370
Page 1 of 2
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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.
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 (OIVD)
Drvision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080370
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