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JAS Diagnostics XL-GLU2-40

by Drew Scientific, Ltd.

JAS Diagnostics XL-GLU2-40 is a Class II device made by Drew Scientific, Ltd., cleared under FDA 510(k) K011900 on 31 Jul 2001 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817274021583), active as of 22 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

2 closed

Documents

510(k) K011900

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817274021583 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011900 Date31 Jul 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011900 decided 31 Jul 2001 Active
  • FDA GUDID UDI-DI 00817274021583 listed 9 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0827-2015 FDA Class II initiated 23 Oct 2014 on shared 510(k) K011900

    Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.

    • Terminated Z-1873-2014 FDA Class II initiated 7 Apr 2014

    JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K011900
  2. Recall initiated FDA recalls Z-1873-2014
  3. Recall initiated FDA recalls Z-0827-2015
  4. Listed FDA GUDID 00817274021583

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
JAS Diagnostics
Generic name
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry
Model / reference
XL-GLU2-40
Description
GLUCOSE HEXOKINASE (5x 40mL)
Primary DI / UDI-DI
00817274021583
510(k) Number
FDA product code
CGA
GMDN term
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

Cleared under the same submission (K011900)

Similar devices

Other devices filed under FDA product code CGA (Glucose Oxidase, Glucose).

Other devices from Drew Scientific, Ltd.

See all devices from Drew Scientific, Ltd. →

Properties

  • Convenience kit
  • Lot / batch number
Other properties (13, all answered No)