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
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K192063Substantially Equivalent

PGDx elio tissue complete

Personal Genome Diagnostics Inc., Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192063 is the FDA 510(k) clearance record for PGDx elio tissue complete, a class II device, cleared for Personal Genome Diagnostics on under FDA product code PZM (Next Generation Sequencing Based Tumor Profiling Test). FDA's definition for product code PZM reads: "A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens...". FDA records list 2 510(k) clearances for Personal Genome Diagnostics, from to . As of , FDA records show no recalls naming K192063.

Clearance record

Decision date
Received
(267 days to decision)
Product code
PZM Next Generation Sequencing Based Tumor Profiling Test
Regulation
21 CFR 866.6080
Device class
Class II
Review panel
Pathology
Applicant
Personal Genome Diagnostics 2809 Boston St. Suite 503, Baltimore MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZM

Trailing 12 months
1 clearance under product code PZM in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260