(126 days)
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Not Found
No
The provided text describes a critical care analyzer for measuring various blood parameters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description or intended use.
No
This device is an in vitro diagnostic (IVD) analyzer used for quantitative determination of various analytes in blood, not for treating or preventing disease.
Yes
The device is intended for "in vitro diagnostic use" and performs "quantitative determination" of various substances in blood, which are characteristics of a diagnostic device.
No
The device is described as an "Analyzer" and uses "Calibrator Cartridge" and "Controls," which are physical components, indicating it is a hardware device with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states the following:
- "The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals..."
- "The intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin... in human blood using the Stat Profile Critical Care Xpress CO-Oximeter Analyzer."
- "Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers."
These statements clearly indicate that the device and its associated components are intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (02Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Gu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.
The intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin and total bilirubin in human blood using the Stat Profile Critical Care Xpress CO-Oximeter Analyzer.
Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers.
Product codes
CIG, JIT, JJY
Device Description
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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
Total Bilirubin (tBil) was not evaluated on neonatal samples.
Intended User / Care Setting
health care professionals and for point-of-care usage
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)
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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.
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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
Not Found
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Paul W. MacDonald Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454
NOV - 1 2006
Re: K061830
Rootess Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, JIT, JJY Dated: October 17, 2006 Received: October 18, 2006
Dear Mr. MacDonald:
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 I ou mayy arosses 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 n may ou our 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 equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits 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) 276-0484. Also, please note 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Alberto Gutierrez, Ph.D.
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
UNI, 1572 M
510(k) Number: Device Name: Indications for Use:
Kae1850
Nova Stat Profile Critical Care Xpress (CCX 1+) SystemThe Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care r rofessionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (02Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Gu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.
The intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin and total bilirubin in human blood using the Stat Profile Critical Care Xpress CO-Oximeter Analyzer.
Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Autocartridge QC are intended for in r vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
|---|
Division Sign-Off
| Offic: | Diagnostic L. . U. |
|---|---|
| Evaluation and Safety | (Updated Febru. |
| K061830 |
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