NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

K153165 · Astute Medical, Inc. · PIG · Jun 1, 2016 · Clinical Chemistry

Device Facts

• Record ID: K153165
• Device Name: NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
• Applicant: Astute Medical, Inc.
• Product Code: PIG · Clinical Chemistry
• Decision Date: Jun 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1220
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Acute Kidney Injury (AKI) Risk Assessment	The NEPHROCHECK® Test Kit met its specifications for performance parameters including interference, stability, and detection capability.	The modified NEPHROCHECK® Test Kit met its specifications; no new risks were introduced.	Not applicable (Special 510(k) for device modifications).	Bench testing conducted to verify performance parameters including interference (myoglobin), shelf-life/stability (2-8°C, ambient shipping, open-bottle, room temperature handling), cycling effects, equilibration time, and detection capability (for second supplier of anti-IGFBP-7).

Indications for Use

The NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment for acute kidney injury (AKI) in patients who are critically ill or are otherwise admitted to the intensive care unit (ICU). The NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment for acute kidney injury (AKI) in patients who are critically ill or are otherwise admitted to the intensive care unit (ICU).

Device Story

System uses urine samples to measure protein biomarkers IGFBP-7 and TIMP-2; utilizes single-use cartridge with membrane test strip and fluorescent conjugate; operated by trained medical professionals in central laboratory. Operator mixes urine with conjugate, inserts cartridge into ASTUTE140® Meter; meter performs incubation, reads fluorescent signal, calculates AKIRISK™ Score, and displays result on LCD. Internal procedural controls monitor cartridge function; errors prevent result reporting. Score aids clinicians in assessing AKI risk; facilitates early clinical intervention for patients with cardiovascular/respiratory compromise.

Clinical Evidence

Bench testing only; verification and validation activities performed based on risk analysis to confirm that modifications (labeling, storage, antibody supplier) do not impact device performance or intended use.

Technological Characteristics

Immunoassay-based test system; utilizes anti-IGFBP-7 antibodies; modified storage conditions (2-8°C); fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for risk assessment of acute kidney injury (AKI) in critically ill patients or those admitted to the ICU.

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 (K131650)
• NEPHROCHECK® Test System (DEN130031)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K153165

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a pre-amendments device, a statement to this effect has been provided.) NEPHROCHECK Test System, DEN130031.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

a. Labeling changes to the NEPHROCHECK® Test instructions for use to add myoglobin as a substance that does not exhibit interference with the AKIRISK™ Score in the "Interfering Substances" section of the Performance Characteristics section.
b. Labeling changes to the "Storage and Handling Requirements" section of the NEPHROCHECK® Test instructions for use to change the storage conditions to 2-8°C and extend the shelf life stability claim for the NEPHROCHECK® Test System.
c. Addition of a second supplier for anti-IGFBP-7 antibody.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics and performance characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their pre-amendment) device.