Data / Medical devices / United States / The Binding Site, Inc.
The Binding Site, Inc.: FDA-registered device maker in San Diego, CA, United States, 4 510(k) clearances
The Binding Site, Inc. is registered with the FDA (registration 2083566) in San Diego, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 23, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2083566
- Address
- 9606 Kearny Villa Rd, San Diego, CA, United States, 92126
- Owner or operator
- THE BINDING SITE, INC. (2083566)
- Roles
- Manufacturer
- First device listed
- January 27, 2026
- Registered through
- 2027
- Brand names listed
- Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems, Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems, Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit, Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kappa, Antigen, Antiserum, Control | DFH | 2 | Manufacturer | accessdata.fda.gov |
| Lambda, Antigen, Antiserum, Control | DEH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2025 | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | DFH | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 23, 2018 | K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | DFH | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 26, 2015 | K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | DFH | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| November 30, 2007 | K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | DFH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 27, 2003 | 26433 | Not yet classified | Terminated | Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029 | Risk of false positives. | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.