510(k) · Cleared
ClearedLyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)
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 K883767 (Hillcrest Biologicals, 1989) after a 439-day review. Its family tree reaches back 1 generation to 1989.
- 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 K883767 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK883767 Lyme Disease Ifa (Igm)Hillcrest Biologicals · 1989
- This deviceK971007 Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)Mrl Diagnostics · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883767 | Lyme Disease Ifa (Igm) | Hillcrest Biologicals | 1989 | — |
| 0 (this device) | K971007 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M) | 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 |
|---|---|---|---|
| * | K883767 | Lyme Disease Ifa (Igm)Summary page 1…1 Western Blot IgM Classification: Lyme Disease Borrelia burgdorferi Serological Reagents 21 CFR §866.3830 Class II Predicate MRL Diagnostics Lyme Disease IFA IgM kit (K883767) Device: 10703 PROGRESS WAY, CYPRESS CALIFORNIA 90630 800 445-0185 714 220-1900 FAX « 714 220-1182 [email protected] === Page… | 1989 |
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 Borrelia burgdorferi Genogroup 1 Western Blot IgM test allows the qualitative detection of IgM class antibody in human serum to individual proteins of the genogroup 1 (B. burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot assay is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease, using serum samples…
Read the full statement (165 words)
MRL Diagnostics’ Lyme Disease Borrelia burgdorferi Genogroup 1 Western Blot IgM test allows the qualitative detection of IgM class antibody in human serum to individual proteins of the genogroup 1 (B. burgdorferi sensu stricto) of B. burgdorferi sensu lato. The MRL Diagnostics Lyme Disease B. burgdorferi Western Blot assay is intended to provide supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease, using serum samples which have been found positive or equivocal by another B. burgdorferi detection methodology (e.g. IFA or ELISA).
The MRL Diagnostics Lyme Disease B. burgdorferi Genogroup 1 Western Blot IgM can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected patients are usually found to be Western Blot positive for IgG. For persons beyond the acute phase, a positive IgM test alone is not recommended for determining active disease in patients. Therefore, both IgG and IgM Western Blots should be used after the acute phase.
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/K971007 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971007: Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971007
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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