510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100287Substantially Equivalent

Jbaids Influenza A/h5 Detection Kit, Model Jrpd-Asy-0136

U.S. Army Medical Material Development Command, Fort Detrick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100287 is the FDA 510(k) clearance record for JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136, a class II device, cleared for U.S. Army Medical Material Development Command on under FDA product code NXD (Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna). FDA's definition for product code NXD reads: "Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and...". FDA records list one 510(k) clearance for U.S. Army Medical Material Development Command. As of , FDA records show no recalls naming K100287.

Clearance record

Decision date
Received
(158 days to decision)
Product code
NXD Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Regulation
21 CFR 866.3332
Device class
Class II
Review panel
Microbiology
Applicant
U.S. Army Medical Material Development Command 1430 Veterans Dr., Fort Detrick MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXD

Trailing 12 months

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

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