Who else makes this device?

Name: Pointe Scientific, Inc. Lipase-Color
Brand: Pointe Scientific, Inc. Lipase-Color

Clinical Chemistry › Test SystemsLipase-Esterase, Enzymatic, Photometric, Lipase

Pointe Scientific, Inc. Lipase-Color

Pointe Scientific, Inc. Lipase-Color Reagent for the in vitro quantitative kinetic determination of Pancreatic Lipase in serum. 10 x 10 ml

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CHI
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70

Record

Regulatory record for Pointe Scientific, Inc. Lipase-Color
Listed by	Horiba Instruments Incorporated, United States
FDA product code	CHI
Device type	Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class	Class 1
Regulation	21 CFR 862.1465
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K897150
Record published	2016-08-31
Record revised	2025-10-02 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Pointe Scientific, Inc. Lipase-Color
Catalogue number	Size	Status
L7503-100		In distribution
L7503-40		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	7
Lipase (LPS)	Randox Laboratories Limited	4
Carolina Liquid Chemistries Corp.® Lipase Reagent KIT ST621	Carolina Liquid Chemistries	4
Lipase colorimetric assay	Roche Diagnostics Gmbh	3
Architect	Abbott Ireland	2
Vitros	Ortho-Clinical Diagnostics, Inc.	2
Alinity	Abbott Ireland	2
Architect	Abbott Laboratories	1
Dimension Vista® Flex® reagent cartridge Lipl	Siemens Healthcare Diagnostics Inc	1
MedTest Dx, Inc. Lipase (Colorimetric)	Medtest DX	1
Lipase NG OC Reagent Kit	Sentinel CH. SPA	1
Lipase colorimetric	Roche Diagnostics Gmbh	1

Showing 12 of 28. All products under Lipase-Esterase, Enzymatic, Photometric, Lipase

Recalls Naming This Product

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

Recalls naming the identifiers of Pointe Scientific, Inc. Lipase-Color
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Genzyme Corporation	510(k) number	2008-04-14	Not classified	Nonconforming Material/Component	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.	3,443	2008-09-16
Genzyme Corporation	510(k) number	2008-04-14	Not classified	Nonconforming Material/Component	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.	3,443	2008-09-16
Genzyme Corporation	510(k) number	2008-04-14	Not classified	Nonconforming Material/Component	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.	3,443	2008-09-16
Genzyme Corporation	510(k) number	2008-04-14	Not classified	Nonconforming Material/Component	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.	3,443	2008-09-16

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
2018-10-30	Class II	Device Design	Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal b	1539 Chemistry Analyzers	2020-06-16

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.