510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K192073Substantially Equivalent

Helix Genetic Health Risk App for late-onset Alzheimer’s disease

Helix Opco, LLC, Toronto, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192073 is the FDA 510(k) clearance record for Helix Genetic Health Risk App for late-onset Alzheimer’s disease, a class II device, cleared for Helix Opco, LLC on under FDA product code PTA (Genetic Variant Detection And Health Risk Assessment System). FDA's definition for product code PTA reads: "A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users...". FDA records list 2 510(k) clearances for Helix Opco, LLC. As of , FDA records show no recalls naming K192073.

Clearance record

Decision date
Received
(509 days to decision)
Product code
PTA Genetic Variant Detection And Health Risk Assessment System
Regulation
21 CFR 866.5950
Device class
Class II
Review panel
Immunology
Applicant
Helix Opco, LLC 96 Colbeck St., Toronto, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PTA

Trailing 12 months

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

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