HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS— 510(k) K122066

Clearance details

Applicant

The Binding Site Group , Ltd.

Product code

Code JZG

Device class

Class 2

Regulation

21 CFR 866.5630

Advisory panel

Immunology

Date received

2012-07-16

Decision date

2012-08-30

Decision

Substantially Equivalent

Clearance type

Special

Location

Birmingham, GB

• K161297 — Beta-2-Microglobulin2016-06-07
• K110874 — ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR2012-01-20
• K083289 — HUMAN BETA-2 MICROGLOBULIN KIT2009-05-06
• K083463 — DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M2009-03-13
• K072078 — QUANTIA BETA-2 MICROGLOBULIN, MODEL: 3028223072007-12-19

• K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser2025-10-17
• K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit2025-05-23
• K192116 — Human IgA liquid reagent kit for Use on SPAPlus2019-09-04
• K191985 — Optilite IgA Kit2019-08-19
• K191635 — Optilite IgM Kit2019-07-15

• Z-1301-2018 — Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.Class II·Terminated·The Binding Site Group, Ltd.·20180309

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122066.