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

Immunoglobulin A Kappa Heavy & Light Chain Combined

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

OPX is the FDA product code for Immunoglobulin A Kappa Heavy & Light Chain Combined, a class II device type, regulated under 21 CFR 866.5510. FDA's definition for this code reads: "Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OPX
Device name
Immunoglobulin A Kappa Heavy & Light Chain Combined
FDA definition
Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code OPX

By decision year
3 clearances under product code OPX with a decision year between 2014 and 2016, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OPX by decision year
YearClearances
20141
20151
20161

Applicants with the most clearances

Product code OPX
Applicants holding the most 510(k) clearances under product code OPX
ApplicantClearances
The Binding Site Group Ltd.2
The Binding Site1

Companies listing this code with FDA

Companies whose registered establishments list this code