510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241453Substantially Equivalent

Elecsys sFlt-1 and Elecsys PlGF

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241453 is the FDA 510(k) clearance record for Elecsys sFlt-1 and Elecsys PlGF, a class II device, cleared for Roche Diagnostics on under FDA product code QWH (Prognostic Test For Development Or Progression Of Preeclampsia). FDA's definition for product code QWH reads: "A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is...". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K241453.

Clearance record

Decision date
Received
(261 days to decision)
Product code
QWH Prognostic Test For Development Or Progression Of Preeclampsia
Regulation
21 CFR 862.1602
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QWH

Trailing 12 months

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

FDA records show no clearances under product code QWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWH, 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