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

Procalcitonin Assay

21 CFR 866.3215 / Microbiology
FDA source (opens on fda.gov)

PRI is the FDA product code for Procalcitonin Assay, a class II device type, regulated under 21 CFR 866.3215. FDA's definition for this code reads: "To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of...". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PRI
Device name
Procalcitonin Assay
FDA definition
To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code PRI

By decision year
8 clearances under product code PRI with a decision year between 2017 and 2022, 2017 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PRI by decision year
YearClearances
20174
20182
20201
20221

Applicants with the most clearances

Product code PRI
Applicants holding the most 510(k) clearances under product code PRI
ApplicantClearances
Roche Diagnostics GmbH2
B.R.A.H.M.S GmbH1
Diasorin Inc.1
Fisher Diagnostics1
Fujirebio Diagnostics, Inc.1
Siemens Healthcare Diagnostics Inc.1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code