Who else makes this device?

Name: Alere Cholestech LDX®
Brand: Alere Cholestech LDX®

Alere Cholestech LDX® · Glucose Oxidase, Glucose → Clinical Chemistry

8manufacturers in China registered for this device type

4catalogue numbers in this listing

1510(k) clearance

4recalls on this code

Who Else Makes It

Concentrated in Guangdong (3), Zhejiang (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CGA
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24
Flextronics Industrial (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	5
Yasee Biomedical Inc	Qingdao	Shandong	Contract manufacturer	5
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Vivachek Biotech (Hangzhou) Co., Ltd.	Hangzhou, Zhuji	Zhejiang	Contract manufacturer	21
Shenzhen Yuwen E-Commerce Co., Ltd.	Shenzhen	Guangdong	Repacker / relabeller	19
Tianjin Empecs Medical Device Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	8

Record

Regulatory record for Alere Cholestech LDX®
Listed by	Alere San Diego, Inc., United States
FDA product code	CGA
Device type	Glucose Oxidase, Glucose
Device class	Class 2
Regulation	21 CFR 862.1345
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-06-29
Record revised	2026-03-13 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Storage environment temperature 2 to 8 °C
Distribution end date	2022-05-26

Catalogue Numbers

Catalogue numbers for Alere Cholestech LDX®
Catalogue number	Size	Status
99021		In distribution
14-531		In distribution
10-991		Withdrawn
10-990		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
i-STAT	Abbott Point OF Care Inc.	48
YSI Incorporated	YSI Incorporated	34
Auvon	Shenzhen Yuwen E-Commerce Co., Ltd.	28
Stat Profile	Nova Biomedical Corporation	17
Fora	Fora Care Inc.	13
TRUEtrack	Trividia Health, Inc.	12
JAS Diagnostics	Drew Scientific, Ltd.	11
StatStrip	Nova Biomedical Corporation	9
Gluc-PAP	Randox Laboratories Limited	8
Nova Primary	Nova Biomedical Corporation	8
Synermed®	Infrared Laboratory Systems LLC	7
Prodigy No Coding Blood Glucose Test Strips	Prodigy Diabetes Care, LLC	7

Showing 12 of 215. All products under Glucose Oxidase, Glucose

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K223179	2023-09-20

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Alere Cholestech LDX®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Alere San Diego, Inc.	UDI-DI	2022-06-24	Class II	Device Design	Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated)	436,990

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2024-03-01	Class II	Labeling design	There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to	559 units
2013-10-23	Class III	Labeling Change Control	Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-991, Lot # 320167, becuase an incorrect lot number was printed on the outer 10 pack kit box label. The incorrect Lot # number printed was 321067.	3,621 kits	2014-09-25
2011-02-18	Not classified	Pending	The recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of the true value of th	5,305 Boxes	2012-04-02

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P990026	2002-02-04	CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER	Animas Corp.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Alere Cholestech LDX®