Who else makes this device?

Name: AmediCheck Instant Test Cup
Brand: AmediCheck Instant Test Cup

AmediCheck Instant Test Cup · Enzyme Immunoassay, Cannabinoids → Clinical Chemistry

18manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

7recalls on this code

Who Else Makes It

Concentrated in Zhejiang (9), Guangdong (4), Beijing (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LDJ
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Assure Tech. (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
Hangzhou Biotest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	41
Abon Biopharm (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	17
Core Technology Co., Ltd.	Changping District	Beijing	Contract manufacturer	14
Prometheus Bio Inc.	Hangzhou	Zhejiang	Contract manufacturer	12
Hangzhou AllTest Biotech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	48
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	44
W.h.p.m. Bioresearch & Technology Co., Ltd.	Beijing	Beijing	Manufacturer	37
Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou	Guangdong	Complaint-file establishment	35
Changchun Wancheng BIO-Electron Co., Ltd.	Changchun	Jilin	Contract manufacturer	34
Co-Innovation Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	29

Showing 12 of 18. All 18 manufacturers in China registered for Enzyme Immunoassay, Cannabinoids

Record

Regulatory record for AmediCheck Instant Test Cup
Listed by	Ameditech, Inc., United States
FDA product code	LDJ
Device type	Enzyme Immunoassay, Cannabinoids
Device class	Class 2
Regulation	21 CFR 862.3870
Establishment	Complaint-file establishment, Manufacturer
510(k)	K063379
Record published	2017-03-31
Record revised	2023-11-14 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Over the counter	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 36 to 86 °F; Storage environment temperature 2 to 30 °C
Distribution end date	2019-01-29

Catalogue Numbers

Catalogue numbers for AmediCheck Instant Test Cup
Catalogue number	Size	Status
C-C1016A		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
DrugCheck	Express Diagnostics Int’l., Inc.	378
Advin Multi-Drug Screen Test	Advin Biotech, Inc.	234
DrugCheck	Express Diagnostic Int’l, Inc.	167
T-Cup	Wondfo USA Co., Ltd.	63
Wondfo Drug Test Dip Card	Wondfo USA Co., Ltd.	56
Enzyme Immunoassay, Cannabinoids	Alere San Diego, Inc.	48
Premier Bio-Cup & Bio-Dip	Premier Biotech, LLC	46
Enzyme Immunoassay, Cannabinoids	W.h.p.m., Inc.	35
MD DugScreen	Medical Disposables Corp	24
AllSource Screening Solutions – Drug Detector	Allsource Screening Solutions	18
Preview	Wondfo USA Co., Ltd.	18
Identify Diagnostics Drug Test Cups	Medical Distribution Group Inc	17

Showing 12 of 288. All products under Enzyme Immunoassay, Cannabinoids

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K011813	2001-10-22

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of AmediCheck Instant Test Cup
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Ameditech, Inc.	510(k) number	2017-09-30	Class III	Nonconforming Material/Component	Product was released to market without the adulteration strip included in the product.	40 kit boxes (1000 units)	2019-08-06
Branan Medical Corporation	510(k) number	2016-07-05	Class III	Labeling mix-ups	Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.	96 units	2016-10-04

Recalls

7 of these are Class II. Class II means a temporary or reversible health consequence. 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
2020-08-18	Class II	Process control	Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.	31,600 units	2024-09-30
2020-08-18	Class II	Process control	Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.	47,005 units	2024-09-30
2020-08-18	Class II	Process control	Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.	136,925 units	2024-09-30
2020-08-18	Class II	Process control	Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.	13,700 units	2024-09-30
2020-08-18	Class II	Process control	Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.	31,800 units	2024-09-30
2020-08-18	Class II	Process control	XXX	1,325 units	2024-09-30
2020-08-18	Class II	Process control	Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.	120, 150	2024-09-30

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
P950040	1997-01-21	DR. BROWN’S HOME DRUG TESTING KIT	Personal Health & Hygiene, Inc.

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.

AmediCheck Instant Test Cup