Who is the manufacturer of ProNephro AKI (NGAL)?

Bioporto Diagnostic, Inc. submitted the Traditional clearance for ProNephro AKI (NGAL) (K232761).

What is the FDA product code for ProNephro AKI (NGAL)?

PIG. It is classified under 21 CFR 862.1220 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ProNephro AKI (NGAL)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ProNephro AKI (NGAL)?

Nephrocheck Test System (DEN130031).

ProNephro AKI (NGAL)

K232761 · Bioporto Diagnostic, Inc. · PIG · Dec 7, 2023 · Clinical Chemistry

Device Facts

Record ID	K232761
Device Name	ProNephro AKI (NGAL)
Applicant	Bioporto Diagnostic, Inc.
Product Code	PIG · Clinical Chemistry
Decision Date	Dec 7, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1220
Device Class	Class 2
Attributes	Pediatric

Intended 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 < 22 years) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant. ProNephro AKI™ (NGAL) is intended to be used in the first 24 hours of ICU admission. In patients with low SCr levels, indicative of no acute kidney injury (AKI) or AKI Stage 1, the test can be used as an aid to identify patients at risk to develop moderate to severe acute kidney injury (Stage 2/3 AKI) 48 to 72 hours after the time of assessment. In patients with an elevated SCr level, indicative of Stage 2/3 AKI, the test can be used as an aid to identify patients at risk to have persistent moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. The particle-enhanced turbidimetric immunoassay is intended for use on the Roche cobas® c 501 clinical chemistry analyzer.

Device Story

ProNephro AKI™ (NGAL) is a quantitative immunoassay for human urine; used in ICU settings by laboratory staff. Input: urine sample; Principle: particle-enhanced turbidimetric immunoassay (PETIA) using polystyrene microparticles coated with mouse monoclonal anti-NGAL antibodies. NGAL in sample causes agglutination; light scattering measured at 570 nm. Output: NGAL concentration (ng/mL) interpolated from calibration curve. Clinicians use result alongside full clinical assessment to identify pediatric patients at risk for moderate/severe AKI (Stage 2/3) 48-72 hours post-assessment. Benefit: aids early risk stratification for AKI in critically ill pediatric patients.

Clinical Evidence

Multi-center prospective study (n=514 evaluable pediatric patients). Primary endpoint: risk assessment of moderate/severe AKI (Stage 2/3) 48-72 hours post-assessment. Overall sensitivity 72.3% (95% CI: 57.4-84.4%), specificity 86.3% (95% CI: 82.8-89.3%). NPV 96.9%, PPV 34.7%. Subgroup analysis provided for patients with/without elevated baseline SCr.

Technological Characteristics

Particle-enhanced turbidimetric immunoassay. Reagents: R1 (tris-buffer, murine protein) and R2 (polystyrene microparticles coated with mouse monoclonal anti-NGAL antibodies). Energy source: optical (photometric) detection on Roche cobas c 501 analyzer. Measuring range: 50-3000 ng/mL. Connectivity: instrument-specific. Sterilization: N/A (reagents).

Indications for Use

Indicated for pediatric patients (≥ 3 months to < 22 years) without underlying kidney disease admitted to the ICU for cardiovascular/respiratory compromise or post-transplant (solid organ/bone marrow). Used within 24 hours of ICU admission to assess risk of developing or having persistent moderate to severe AKI (Stage 2/3) 48-72 hours post-assessment.

Regulatory Classification

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.

Special Controls

Acute kidney injury test systems must comply with the following special controls: 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 failure to correctly interpret 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 (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.

*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 820.10(c) design and development activities, you must document the appropriate end user device training program provided in your premarket notification submission to satisfy the special control in paragraph (b)(1) of this section 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.

Predicate Devices

Nephrocheck Test System (DEN130031)

Related Devices

K210793 — VIDAS NEPHROCHECK · Biomérieux SA · Jul 8, 2022
DEN130031 — NEPHROCHECK TEST SYSTEM · Astute Medical, Inc. · Sep 5, 2014
K171482 — NEPHROCHECK Test System · Astute Medical, Inc. · Nov 16, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text. 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). {1}------------------------------------------------ 2 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 {2}------------------------------------------------ ## 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 < 22 years) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant. ProNephro AKI™ (NGAL) is intended to be used in the first 24 hours of ICU admission. In patients with low SCr levels, indicative of no acute kidney injury (AKI) or AKI Stage 1, the test can and to identify patients at risk to develop moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. In patients with an elevated SCr level, indicative of Stage 2/3 AKI, the test can be used as an aid to identify patients at risk to have persistent moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. The particle-enhanced turbidimetric immunoassay is intended for use on the Roche cobas c 501 clinical chemistry analyzer. Type of Use (*Select one or both, as applicable*) | <div> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Bioporto Diagnostics. The logo features a stylized atom-like graphic to the left of the word "bioporto" in a sans-serif font. Below "bioporto" is the word "DIAGNOSTICS" in a smaller, sans-serif font. # 510(k) Summary ProNephro AKI™ (NGAL) BioPorto Diagnostics Inc. 117 Fourth Avenue, Suite 202 Needham, MA 02494 USA {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for "bioporto DIAGNOSTICS". To the left of the word "bioporto" is a graphic of a central circle with eight smaller circles surrounding it. The word "bioporto" is in a bold, sans-serif font. Below "bioporto" is the word "DIAGNOSTICS" in a smaller, sans-serif font. #### 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): K232761 #### Purpose for Submission 2. To obtain a substantial equivalence determination for the ProNephro AKI™ (NGAL) in a pediatric population (≥ 3 months to < 22 years) admitted to the pediatric intensive care unit (PICU). #### 3. Measurand Neutrophil gelatinase-associated lipocalin (NGAL) #### 4. Type of Test Quantitative, particle-enhanced turbidimetric immunoassay #### 5. Applicant BioPorto Diagnostics Inc. #### Proprietary and Established Names 6. ProNephro AKI™ (NGAL) {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Bioporto Diagnostics. The logo consists of a stylized atom-like graphic on the left, followed by the text "bioporto" in a bold, sans-serif font. Below "bioporto" is the word "DIAGNOSTICS" in a smaller, lighter font. #### Regulatory Information 7. #### Assay | Trade Name: | ProNephro AKI™ (NGAL) | |------------------|---------------------------------| | Classification: | Class II, 510(k) required | | Regulation: | 21 CFR 862.1220 | | Regulation Name: | Acute Kidney Injury Test System | | Product Code: | PIG | | Panel: | Clinical Chemistry | #### 8. Indications for Use #### 8.1. 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 < 22 years) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant. ProNephro AKI™ (NGAL) is intended to be used in the first 24 hours of ICU admission. In patients with low SCr levels, indicative of no acute kidney injury (AKI) or AKI Stage 1, the test can be used as an aid to identify patients at risk to develop moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. In patients with an elevated SCr level, indicative of Stage 2/3 AKI, the test can be used as an aid to identify patients at risk to have persistent moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. The particle-enhanced turbidimetric immunoassay is intended for use on the Roche cobas® c 501 clinical chemistry analyzer. #### 8.2. Special Conditions for Use Statement(s) For in Vitro Diagnostics Use and Rx only Warnings and Precautions for the Assay - . This kit should only be used by qualified laboratory staff. - Do not shake the reagents. - . Use only clean containers if transferring reagents. - . Do not pour reagents back into the original containers once transferred. - . All specimens used in this test should be considered potentially infectious, and as such be treated with standard precautions. - . Powder-free gloves should be worn. Avoid direct skin contact. Should reagents come into contact with the skin, eyes or mouth, flush with plenty of water. Seek medical advice if any symptom is observed or when it is considered necessary. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for "bioporto DIAGNOSTICS". The logo features a stylized atom-like graphic to the left of the text. The word "bioporto" is in a bold, sans-serif font, and the word "DIAGNOSTICS" is in a smaller, lighter font below it. - . Reagents contain preservatives with 2-methyl-2H isothiazol-3-one (MIT) which may cause an allergic skin reaction. For more information, please refer to the safety data sheet. - Do not switch caps on reagent containers as it may cause contamination or mix-up. . - . Place calibrators in the correct order onto the instrument to ensure a correct calibration curve. - . Do not use reagents after the expiration date on the labels. - . Reagents with different lot numbers should not be mixed. - . All solutions and samples must be handled carefully and disposed of in accordance with national and local regulations. #### Special Instrument Requirements 8.3. Roche cobas® c 501 clinical chemistry analyzer {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Bioporto Diagnostics. The logo consists of a stylized atom-like graphic on the left, followed by the word "bioporto" in a bold, sans-serif font. Below "bioporto" is the word "DIAGNOSTICS" in a smaller, lighter font. The overall design is clean and modern. #### Device Description 9. Table 1 describes the components required to run a ProNephro AKI™ (NGAL) test. The ProNephro AKI™ (NGAL) Reagent Kit contains Reaction Buffer Reagent (R1) and Immunoparticle Suspension Reagent (R2). The R1 reagent is a ready-to-use tris-buffer solution containing murine protein and preservative. The R2 reagent is a ready-to-use suspension of polystyrene microparticles coated with mouse monoclonal antibodies to NGAL that also contains preservative. The ProNephro AKI Reagent Kit provides enough reagents for 100 tests on the Roche cobas c 501 clinical chemistry analyzer. The finished kit will also include a labeled Roche cassette and two funnels for transferring the reagent into the Roche cassette. The reagents must be transferred to a Roche cassette prior to the cobas c 501. This is done by pouring the R1 reagent into Position B of the cassette and R2 reagent into Position C. The operator will load the cassette onto the instrument and run the ProNephro AKI™ (NGAL) test per the instructions for use. The ProNephro AKI® (NGAL) Calibrator Kit consists of five (5) individual ready-to-use calibrator solutions (1 mL each) comprised of different concentrations (50-3000 ng/mL) of recombinant human NGAL in a HEPES buffer and a preservative. The ProNephro AKI™ (NGAL) Control Kit contains ready-to-use High (500 ng/mL target concentration) and Low (200 ng/mL target concentration) Controls comprised of recombinant human NGAL in HEPES buffer and a preservative. There are three (3) 1 mL bottles of each level included with the kit. | Product Trade Name and Model Number | Kit Components | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | ProNephro AKI™ (NGAL) Reagent Kit ST101UB | Reaction Buffer (R1), 17.9 mL Immunoparticle Suspension (R2), 7.65 mL Roche cobas c 501 cassette and two funnels | | ProNephro AKI™ (NGAL) Calibrator Kit ST102UA | Calibrator 1: 1 mL Calibrator 2: 1 mL Calibrator 3: 1 mL Calibrator 4: 1 mL Calibrator 5: 1 mL | | ProNephro AKI™ (NGAL) Control Kit ST103UA | Control Low: 3 x1 mL Control High: 3 x1 mL | #### Table 1: Test Components {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Bioporto Diagnostics. The logo consists of a stylized atom-like graphic on the left, followed by the word "bioporto" in a sans-serif font. Below "bioporto" is the word "DIAGNOSTICS" in a smaller, sans-serif font. The atom graphic is light blue and gray, while the text is dark gray. ## 10. Substantial Equivalence Information ## 10.1. Predicate Device Name(s) NEPHROCHECK® Test System ## 10.2. Predicate 510(k) Number(s) DEN130031 ## 10.3. Comparison With Predicate ## Table 2: Predicate Device Comparison | ltem | ProNephro AKI™ (NGAL) | NEPHROCHECK® Test System (Predicate Device) | |-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K232761 | DEN130031 | | Intended Use / Indications for 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 < 22 years) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant. ProNephro AKI™ (NGAL) is intended to be used in the first 24 hours of ICU admission. In patients with low SCr levels, indicative of no acute kidney injury (AKI) or AKI Stage 1, the test can be used as an aid to identify patients at risk to develop moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. In patients with an elevated SCr level, indicative of Stage 2/3 AKI, the test can be used as an aid to identify patients at risk to have persistent moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. The particle-enhanced turbidimetric immunoassay is intended for use on the Roche cobas® c 501 clinical chemistry analyzer. | INTENDED USE: The Astute Medical NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older. | | Classification | Class II | Same | | Product Code | PIG | Same | | Test Type | Quantitative immunoassay | Same | | Test Technology | Particle Enhanced Turbidimetric assay | Lateral Flow with fluorescent detection | | Item | ProNephro AKI™ (NGAL) | NEPHROCHECK® Test System (Predicate Device) | | Instrument | Roche cobas c 501 Clinical Chemistry Analyzer | ASTUTE140® Meter | | Measurand | Neutrophil gelatinase-associated lipocalin (NGAL) | Insulin-like growth factor binding protein (IGFBP7) and tissue-inhibitor of metalloproteinases 2 (TIMP2) | | Population | Pediatric (≥ 3 months to < 22 years) | Adult | | Units of Measure | ng/mL | AKI Risk Score | | Assay Measuring Range | 50 ng/mL - 3000 ng/mL | Score 0.04 - 10.0 | | Specimen Type | Urine | Same | | Controls | 2 levels of controls: low and high | Same | | Calibrators | N=5 levels across the measuring range of the assay | Same | | Special Controls | Complies | Same | | Repeatability (within- run) and Intermediate Precision (within- laboratory) | Repeatability (within-run): • 3.8 to 5% below the cutoff (125 ng/mL) • 0.9 to 2.3% from 125 to 500 ng/mL • 1.2 to 1.5% above 500 ng/mL Intermediate Precision (within-laboratory): • 4.9 to 6.6% below the cutoff (125 ng/mL) • 2.2 to 3.4% from 125 to 500 ng/mL • 2.2 to 2.7% above 500 ng/mL | Repeatability (within-run): • 9.5 to 9.7% below the cutoff score (0.3) • 7.4 to 7.8% above the cutoff score (0.3) Intermediate precision (within-laboratory): • 10.2 to 11% below the cutoff score (0.3) • 8.0 to 10.2% above the cutoff score (0.3) | | Reproducibility (multi-site) | Total Imprecision: • 6.2 to 6.6% below the cutoff (125 ng/mL) • 3.6 to 4.8% from 125 to 500 ng/mL • 3.6 to 4.3% above 500 ng/mL | Total Imprecision: • 10.4 to 18.3% below and at the cutoff score (0.3) • 9.1 to 11.7% above the cutoff score (0.3) | | Analytical Sensitivity | LoB = 9 ng/mL LoD = 14 ng/mL LoQ = 18 ng/mL | LoB = 0.0002 LoD = 0.002 LoQ = 0.002 | | Linearity | Linearity confirmed between 49 and 3105 ng/mL | The reportable range of the NEPHROCHECK AKI Risk Score is 0.4 to 10.0. The markers that go into the score were assessed and found to be linear. However, the AKI Risk Score itself is not expected to be linear. | | High Dose Hook Effect | No Hook Effect at NGAL concentrations up to 40,000 ng/mL | No Hook Effect at AKI Risk Score values up to 250. | | Item | ProNephro AKI™ (NGAL) | NEPHROCHECK® Test System (Predicate Device) | | Clinical Performance | Complete Study Population (n=514): | Sensitivity (CI 95%): | | | Sensitivity (CI 95%): | Study A, tested in 3 laboratories: | | | 72.3% (57.4-84.4%) | 90-93% (83-99%) | | | Specificity (CI 95%): | Study B, tested in 1 laboratory: | | | 86.3% (82.8-89.3%) | 76% (60-91%) | | | PPV (CI 95%): | | | | 34.7% (28.5-41.4%) | Specificity (CI 95%): | | | NPV (CI 95%): | Study A, tested in 3 laboratories: | | | 96.9% (95.1-98-0%) | 45-49% (39-54%) | | | Group 1 - patients with Day 0 SCr…

ProNephro AKI (NGAL)