Who else makes this device?

Name: PTS Panels® Creatinine Test Strips
Brand: PTS Panels® Creatinine Test Strips

Clinical Chemistry › Test SystemsEnzymatic Method, Creatinine

PTS Panels® Creatinine Test Strips

PTS Panels® Creatinine test strips are in vitro diagnostic devices used to monitor creatinine levels in human whole blood. These test strips must be used in conjunction with a CardioChek®…

Registry build 21.09.26

PTS Panels® Creatinine test strips are in vitro diagnostic devices used to monitor creatinine levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

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

Chinese manufacturers registered for FDA product code JFY
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Dongguan Honfield Precision Parts Co., Ltd.	Zhangmutou, Dongguan	Guangdong	Contract manufacturer	8
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28
Chong Qing Teco Huayi Pharm. Co.	Shapingba Dist.	Chongqing	Contract manufacturer	18

Record

Regulatory record for PTS Panels® Creatinine Test Strips
Listed by	Polymer Technology Systems, United States
FDA product code	JFY
Device type	Enzymatic Method, Creatinine
Device class	Class 2
Regulation	21 CFR 862.1225
Establishment	Complaint-file establishment, Manufacturer
Record published	2016-07-15
Record revised	2023-07-31 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Keep away from sunlight Keep dry; Bring to room temperature before use; Storage environment temperature 35 to 45 °F; Storage environment temperature 2 to 8 °C
Distribution end date	2019-10-01

Catalogue Numbers

Catalogue numbers for PTS Panels® Creatinine Test Strips
Catalogue number	Size	Per pack	Status
1720		25	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Creatinine Plus	Roche Diagnostics Gmbh	3
Teco Diagnostics	Teco Diagnostics	3
Pointe Scientific, Inc.	Horiba Instruments Incorporated	3
Creatinine plus ver2	Roche Diagnostics Gmbh	3
Architect	Abbott Laboratories	2
CR Cartridge	LifeHealth, LLC	2
Alinity	Abbott Laboratories	2
Creatinine LiquiColor®	Stanbio Laboratory, L.P.	2
Pointe Scientific, Inc. Creatinine Enzymatic	Horiba Instruments Incorporated	2
Automatic Urine Analyzer	Urit Medical Electronic Co., Ltd.	2
Creatinine plus ver.2	Roche Diagnostics Gmbh	1
Dimension® Flex® reagent cartridge Ezcr	Siemens Healthcare Diagnostics Inc	1

Showing 12 of 40. All products under Enzymatic Method, Creatinine

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K010456	2001-06-20

Recalls

1 of these is 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
2012-05-15	Class II	Software design	During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the C	1650 vials	2012-07-20

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.