(90 days)
Not Found
No
The device is an immunoassay for measuring NGAL levels and uses a fixed cutoff value for risk stratification, which does not indicate the use of AI/ML.
No
This device is an in vitro diagnostic immunoassay that quantitatively measures NGAL in human urine to aid in identifying patients at risk of developing or having persistent acute kidney injury, rather than directly treating a condition.
Yes
The document explicitly states the device's "Intended Use / Indications for Use" as an "Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine" to be "used in conjunction with clinical evaluation" to "identify patients at risk to develop moderate to severe AKI (Stage 2/3)" or identify those "at risk to have persistent moderate to severe AKI (Stage 2/3)". These are all clear indications of its diagnostic function.
No
The device is an immunoassay reagent kit and associated calibrators and controls, which are physical components used in a laboratory setting on a clinical chemistry analyzer. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The device is a "Reagent Kit" and includes "Calibrator Kit" and "Control Kit." These are all components used in laboratory testing of biological samples outside of the body.
- Method: The method described is a "particle-enhanced turbidimetric immunoassay," which is a laboratory technique performed on biological samples.
- Sample Type: The test is performed on "human urine."
- Care Setting: The test is intended for use in the "intensive care unit (ICU)" by "qualified laboratory staff," indicating a clinical laboratory setting.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety or suitability of a transfusion or transplantation, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
Determination of NGAL is intended to be used in conjunction with clinical evaluation in pediatric patients (≥ 3 months to
§ 862.1220 Acute kidney injury test system.
(a)
Identification. An acute kidney injury test system is a device that is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must detail an appropriate end user device training program that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results.
(2) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document the appropriate end user device training program provided in your premarket notification submission to satisfy special control 21 CFR 862.1220(b)(1) that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results.
(3) Robust clinical data demonstrating the positive predictive value, negative predictive value, sensitivity and specificity of the test in the intended use population must be submitted as part of the premarket notification submission.
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December 7, 2023
BioPorto Diagnostic Inc. Monika Bak Director Regulatory Affairs Tuborg Havnevej 15, st Hellerup, 2900 Denmark
Re: K232761
Trade/Device Name: ProNephro AKI™ (NGAL) Regulation Number: 21 CFR 862.1220 Regulation Name: Acute Kidney Injury Test System Regulatory Class: Class II Product Code: PIG Dated: September 8, 2023 Received: September 8, 2023
Dear Monika Bak:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-torres -S
Marianela Perez-Torres, PhD Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232761
Device Name ProNephro AKI™ (NGAL)
Indications for Use (Describe)
Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
| Determination of NGAL is intended to be used in conjunction with clinical evaluation in pediatric patients (≥ 3 months to Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
ProNephro AKI™ (NGAL)
BioPorto Diagnostics Inc. 117 Fourth Avenue, Suite 202 Needham, MA 02494 USA
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General Information 1.
| Submission Date: | September 08, 2023 |
|---|---|
| Submitter Information | |
| Submitted By: | BioPorto Diagnostics Inc. |
| 117 Fourth Avenue Suite 202 | |
| Needham MA 02494 | |
| United States | |
| Contact Person: | Monika Bak |
| Director Regulatory Affairs | |
| mbk@bioporto.com |
510(k):
Purpose for Submission 2.
To obtain a substantial equivalence determination for the ProNephro AKI™ (NGAL) in a pediatric population (≥ 3 months to