510(k) · Cleared
ClearedCambridge Biotech Human Lyme Igm Western Blot (90112)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Biotech Corp. · LSR Reagent, Borrelia Serological Reagent
Cleared on Feb 17, 1998 after a 326-day review. The FDA summary names no predicate by number.
- Decided
- Feb 17, 1998
- Review
- 326 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 12.5 · 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?
The FDA summary names no predicate by number.
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.
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?
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is an in vitro test system for the qualitative detection of human Immunoglobulin M (IgM) antibodies to Borrelia burgdorferi antigens in human serum. The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is intended for use in testing human serum samples which have demonstrated positive or equivocal responses using EIA or IFA test procedures to provide supportive evidence of…
Read the full statement (138 words)
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is an in vitro test system for the qualitative detection of human Immunoglobulin M (IgM) antibodies to Borrelia burgdorferi antigens in human serum. The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot is intended for use in testing human serum samples which have demonstrated positive or equivocal responses using EIA or IFA test procedures to provide supportive evidence of infection with Borrelia burgdorferi.
The Cambridge Biotech Human Lyme B. burgdorferi IgM Western Blot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.
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/K971170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971170: Cambridge Biotech Human Lyme Igm Western Blot (90112).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971170
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026