510(k) · Cleared
ClearedLyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mrl Diagnostics · LSR Reagent, Borrelia Serological Reagent
Cleared on Jun 1, 1998 as substantially equivalent to K883487 (Hillcrest Biologicals, 1988) after a 439-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jun 1, 1998
- Review
- 439 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883487 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK883487 Lyme Disease Ifa (Igg)Hillcrest Biologicals · 1988
- This deviceK971006 Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)Mrl Diagnostics · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883487 | Lyme Disease Ifa (Igg) | Hillcrest Biologicals | 1988 | — |
| 0 (this device) | K971006 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G) | Mrl Diagnostics | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LSR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LSR device
- #1 K254295 Sofia Lyme FIA; Sofia 2 Campylobacter FIAscore 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883487 | Lyme Disease Ifa (Igg)Summary page 1…e B. burgdorferi Genogroup 1 Western Blot IgG Lyme Disease Borrelia burgdorferi Serological Reagents 21 CFR §866.3830 Class I MRL Diagnostics Lyme Disease IFA IgG kit (K883487) 10703 PROGRESS WAY, CYPRESS CALIFORNIA 90630 800 445-0185 714 220-1900 FAX » 714 220-1182 [email protected] D… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LSR
133in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSR
1in 2025
MAUDE reports naming product code LSR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 3 | 155 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 53 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 1 | — | 0 | 10 |
| 2017 | 6 | 150 | 0 | 9 |
| 2018 | 3 | 92 | 0 | 4 |
| 2019 | 4 | 86 | 0 | 15 |
| 2020 | 3 | 91 | 0 | 7 |
| 2021 | 6 | 133 | 2 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test is intended for the qualitative detection of IgG class antibodies, in human serum, to the genogroup | (Borrelia burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG test is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease as an aid in the diagnosis…
Read the full statement (165 words)
MRL Diagnostics' Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgG test is intended for the qualitative detection of IgG class antibodies, in human serum, to the genogroup | (Borrelia burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG test is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease as an aid in the diagnosis of Lyme disease, using serum samples which have been found positive or equivocal by a B. burgdorferi screening method (e.g., IFA or ELISA). The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot IgG can be used at any time following onset of symptoms provided the IFA or ELISA is positive or equivocal. Also, it should be used for follow up when: 1) only IgM antibodies were originally detected, 2) IgG antibodies were detected, but were not considered significant by Western blot, or 3) previously seronegative patients subsequently test positive by IFA or ELISA.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971006 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971006: Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971006
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026