510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180559Substantially Equivalent

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

ELITechGroup Inc, Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180559 is the FDA 510(k) clearance record for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius, a class II device, cleared for Elitechgroup on under FDA product code PGI (Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples). FDA's definition for product code PGI reads: "For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid". FDA records list 32 510(k) clearances for Elitechgroup, from to . As of , FDA records show no recalls naming K180559.

Clearance record

Decision date
Received
(242 days to decision)
Product code
PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Regulation
21 CFR 866.3309
Device class
Class II
Review panel
Microbiology
Applicant
Elitechgroup 21720 23rd Dr. SE Suite 150, Bothell WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGI

Trailing 12 months

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

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