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510(k) K153165

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit by Astute Medical, Inc. — Product Code PIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2016
Date Received
November 2, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acute Kidney Injury Test System
Device Class
Class II
Regulation Number
862.1220
Review Panel
CH
Submission Type

An acute kidney injury test system 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 conifmration by alternative methods.

Other clearances by Astute Medical, Inc.

  • K171482 — NEPHROCHECK Test System (November 16, 2017)
  • DEN130031 — NEPHROCHECK TEST SYSTEM (September 5, 2014)

Other clearances for product code PIG

  • K232761 — ProNephro AKI™ (NGAL) (December 7, 2023)
  • K210793 — VIDAS NEPHROCHECK (July 8, 2022)
  • K171482 — NEPHROCHECK Test System (November 16, 2017)
  • DEN130031 — NEPHROCHECK TEST SYSTEM (September 5, 2014)