Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

K-Number: K203292 · 2021-03-22

ApplicantGold Standard Diagnostics
Decision Date2021-03-22
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is a medical device manufactured by Gold Standard Diagnostics. It received FDA 510(k) clearance on 2021-03-22 under approval number K203292. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit?

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is a medical device that received FDA 510(k) clearance on 2021-03-22. It is manufactured by Gold Standard Diagnostics. The 510(k) number is K203292.

When was Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit approved by the FDA?

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit received FDA 510(k) clearance on 2021-03-22, under approval number K203292.

What company makes Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit?

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is manufactured by Gold Standard Diagnostics.

What is the FDA product code for Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit?

The FDA product code for Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit is LSR.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT05281731 Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma RECRUITING NCT06977633 Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 Diabetes NOT_YET_RECRUITING NCT06292299 The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Related PubMed Literature

PMID: 39900769 Regulatory Perspectives for Gene Expression-Based Diagnostic Devices. Methods in molecular biology (Clifton, N.J.) (2025)

Other Devices by Gold Standard Diagnostics

K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit

View all 7 devices →

Related Devices (Code: LSR)

K161513Anti-Borrelia burgdorferi US Westernblot (IgG)Euroimmun US K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)Euroimmun Us, Inc. K172254Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation K163695Borrelia B31 ViraChip IgM Test KitViramed Biotech AG K163504Borrelia B31 ViraChip IgG Test KitViramed Biotech AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑