510(k) · Cleared
ClearedLyme-ID IgG Test; Bio-ID800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inanovate, Inc. · LSR Reagent, Borrelia Serological Reagent
Cleared on Nov 14, 2025 as substantially equivalent to K220016 (Viramed Biotech AG, 2022) after an 86-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Nov 14, 2025
- Review
- 86 days
- Class
- Class II
- Product code
- LSR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K220016 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backK220016 Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG · 2022
- This deviceK252627 Lyme-ID IgG Test; Bio-ID800Inanovate, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K220016 | Viramed Borrela All-In-One ViraChip Test Kit | Viramed Biotech AG | 2022 | — |
| 0 (this device) | K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | 2025 | — |
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? (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 |
|---|---|---|---|
| * | K220016 | Viramed Borrela All-In-One ViraChip Test KitSummary page 8…imultaneously. V. SUBSTANTIAL EQUIVALENCE INFORMATION: A. Predicate Device Name(s): Viramed Borrelia All-In-One ViraChip Test Kit B. Predicate 510(k) Number(s): K220016 C. Comparison with Predicate(s): Device: Predicate:… | 2022 |
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.
- 2 other devices also cite its predicate K220016.
How does its category compare?
All LSR devicesLSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 Inanovate Lyme-ID IgG Test is an in vitro qualitative microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B.burgdorferi antigens following a modified two-tier test methodology. Positive results from the Lyme-ID IgG Test are supportive…
Read the full statement (138 words)
The Inanovate Lyme-ID IgG Test is an in vitro qualitative microarray assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. It is intended to detect antibodies to VlsE and multiple other B.burgdorferi antigens following a modified two-tier test methodology. Positive results from the Lyme-ID IgG Test are supportive evidence for the presence of antibodies and exposure to B. burgdorferi, the causative agent for Lyme disease. Negative results do not preclude infection with B. burgdorferi. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures as an aid in diagnosis of Lyme disease.
The Inanovate Lyme-ID IgG Test must be used with Inanovate’s Bio-ID800 instrument and Lyme-ID Software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252627: Lyme-ID IgG Test; Bio-ID800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252627
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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