510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K232761Substantially Equivalent

ProNephro AKI™ (NGAL)

Bioporto Diagnostic, Inc., Needham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232761 is the FDA 510(k) clearance record for ProNephro AKI™ (NGAL), a class II device, cleared for Bioporto Diagnostic, Inc. on under FDA product code PIG (Acute Kidney Injury Test System). FDA's definition for product code PIG reads: "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...". FDA records list one 510(k) clearance for Bioporto Diagnostic, Inc. As of , FDA records show one recall naming K232761.

Clearance record

Decision date
Received
(90 days to decision)
Product code
PIG Acute Kidney Injury Test System
Regulation
21 CFR 862.1220
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bioporto Diagnostic, Inc. 117 Fourth Ave. Suite 202, Needham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIG

Trailing 12 months

FDA records hold no clearances under product code PIG in the trailing twelve months.

FDA records show no clearances under product code PIG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260