510(k) · Cleared

Cleared

Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit

K980351510(k) TraditionalCleared Mar 5, 1999400-day reviewClass II21 CFR 866.3830

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Biomedica, Inc. · LSR Reagent, Borrelia Serological Reagent

Cleared on Mar 5, 1999 as substantially equivalent to K951709 (Mardx Diagnostics, Inc., 1996) after a 400-day review. Its family tree reaches back 1 generation to 1996.

Decided: Mar 5, 1999
Review: 400 days
Class: Class II
Product code: LSR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951709 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK951709 Mardx Lyme Disease (Igm) Marblot Strip Test SystemMardx Diagnostics, Inc. · 1996
This deviceK980351 Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot KitBoston Biomedica, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951709	Mardx Lyme Disease (Igm) Marblot Strip Test System	Mardx Diagnostics, Inc.	1996	—
0 (this device)	K980351	Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit	Boston Biomedica, Inc.	1999	—

FIG. 1 — Lineage of K980351, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K951709	Mardx Lyme Disease (Igm) Marblot Strip Test System Summary page 1 …dorferi IgM Western blot kit Boston Biomedica, Inc. 375 West Street West Bridgewater, MA 02379 Predicate Device B. burgdorferi (IgM) Marblot Strip Test System 510(k) K951709 MarDx Diagnostics, Inc. 5919 Farnsworth Ct. Carlsbad, CA 92008 Device Description The device is a collection of cGMP manufac…	Mardx Diagnostics, Inc.	1996	—

Also cleared against K951709: 2 other devices →

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 K951709.

How does its category compare?

All LSR devices

LSR Reagent, Borrelia Serological Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LSR

2in 2025

2007high 6 (2017) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LSR

133in 2021

2007high 155 (2012) · low 86 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LSR

1in 2025

2007high 2 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LSR

1in 2025

2007high 53 (2014) · low 0 (2007)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 BBI-Biotech B. burgdorferi IgM Western blot Kit is intended to provide supportive evidence of infection with B. burgdorferi by determining the specific protein reactivities of human serum specimens previously found to be reactive on enzyme immunoassay or indirect immunofluorescence screening assays. The kits will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories.

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/K980351 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980351: Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980351

Report an extraction error

Are you the manufacturer?

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