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FDA product code · Microbiology · Class 2

LSR: Reagent, Borrelia Serological Reagent

LSR is FDA's product code for "Reagent, Borrelia Serological Reagent": a Class 2 device classified under 21 CFR 866.3830, reviewed by the Microbiology panel.

510(k) review time for LSR

Across 22 510(k) clearances under LSR decided from 2018-01-01 to 2026-10-06, the median was 123 days from FDA receipt to decision. Half took between 90 and 167 days, and 80% were decided within 186 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, LSR, decisions 2018-01-01 to 2026-10-06 (n = 22)
Fastest66
25th percentile90
Median123
75th percentile167
80th percentile186
90th percentile258
Slowest315

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

LSR in the public FDA record

Records naming LSR, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years112

Counts of records, not of devices or events. Adverse event reports for LSR are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite LSR

1 FDA recognized consensus standard cite LSR, among them CLSI M34-A (Replaces M24-P). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 7-180 CLSI M34-A (Replaces M24-P) — Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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