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Optilite Freelite Lambda Kit LK018.OPT.A

by The Binding Site Group

Optilite Freelite Lambda Kit LK018.OPT.A is a Class II device made by The Binding Site Group, cleared under FDA 510(k) K231290 on 24 Jan 2024 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05051700017800), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) from GUDID NumberK231290 Date24 Jan 2024IssuedStatusActive
United StatesGUDID listing Number05051700017800 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231290 decided 24 Jan 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05051700017800 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1043-2017 FDA Class II initiated 5 Jul 2016

    Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.

Timeline

4 dated events

  1. Cleared FDA 510(k) K150658
  2. Recall initiated FDA recalls Z-1043-2017
  3. Listed FDA GUDID 05051700017800
  4. Cleared FDA 510(k) K231290

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Optilite Freelite Lambda Kit
Generic name
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Model / reference
LK018.OPT.A
Primary DI / UDI-DI
05051700017800
510(k) Number
FDA product code
DEH
GMDN term
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Device class
Class II
Regulation number
866.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

Cleared under the same submission (K150658)

Cleared under the same submission (K231290)

Similar devices

Other devices filed under FDA product code DEH (Lambda, Antigen, Antiserum, Control).

Other devices from The Binding Site Group

See all devices from The Binding Site Group →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)