FDA.reportPublic FDA data

Lipid Panel, 15ct., CCPlus Home

Primary DI
10381934753017
Brand
Lipid Panel, 15ct., CCPlus Home
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
REF 4753
Catalog number
REF 4753
Device description
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGYColorimetric Method, TriglyceridesClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151545000CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemPolymer Technology Systems, Inc.2016-12-22CHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381934753010PrimaryGS10
10381934753017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381934753010003819347530103819347530100381934753010
1038193475301710381934753017

GMDN Terms#

Term, Definition table
TermDefinition
Multiple lipid analyte IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen, using an enzyme spectrophotometry method. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Keep dry
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)870-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381931716018PTS Panels® Triglycerides Test Strips171617162016-07-22
00381934770017CholesterolREF 477047702025-06-16
00381934774015PTS Diagnostics Capillary TubesREF 477447742025-06-16
10381934770014CholesterolREF 477047702025-06-16
10381934774012PTS Diagnostics Capillary TubesREF 477447742025-06-16
00381933080018A1CNow Self Check, 8ct.308030802023-10-25
10381933080015A1CNow Self Check, 8ct.308030802023-10-25
00381934750019CardioChek Plus Home Self-Test Analyzer475047502022-04-11
00381934720012CardioChek Plus Home Self-Test Analyzer472047202021-02-08
00381931708013CardioChek® PA analyzer170817082016-07-15
00381931709010CardioChek® Analyzer170917092016-07-15
00381931757011CardioChek® PA Professional Analyzer, Refurbished175717572016-07-15
00381931782013CardioChek® Analyzer; Refurbished178217822016-07-15
00381932700016CardioChek® Plus Professional Analyzer270027002016-07-15
00381932701013CardioChek® Plus Professional Analyzer270127012016-07-15
00381932702010CardioChek® Plus Professional Analyzer, Refurbished270227022016-07-15
00021292015022TRUE+ A1CNow Self Check307530752023-07-30
00381932488013Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30
10021292015029TRUE+ A1CNow Self CheckC8H01-02C8H01-022023-07-30
10381932488010Assy Vial, eGLU, 13 ct.REF 2488REF 24882023-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.JGY2026-06-03
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.JGY2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.JGY2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.JGY2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.JGY2026-03-09
10682607690074Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.JGY2026-03-09
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.JGY2024-07-12
00893038002913Cholestech LDX™Alere San Diego, Inc.JGY2023-12-20
00893038002937Cholestech LDX™Alere San Diego, Inc.JGY2023-12-20
06936895301929BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
06936895301936BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
06936895301943BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
06936895301950BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGY2023-07-26
00381934753010Lipid Panel, 15ct., CCPlus HomePOLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-06-20
00381934752013Lipid + eGLU Smart Bundle™ , CC Plus Home (15-pk)POLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-06-01
00887473000337STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-05-10
00887473000344STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-05-10
00887473000320STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.JGY2023-04-07
00381934747019Assy Vial, Lipid Panel Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-03-25
00381934749013Assy Vial, Lipid Panel Test Strips, 1 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.JGY2023-03-25
00887473000290STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-03-17
00887473000306STANDARD™ LipidoCare Lipid Test Strip - Lipid ProfileSD Biosensor, Inc.JGY2023-03-17
00887473000283STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.JGY2023-03-17
00381934750019CardioChek Plus Home Self-Test AnalyzerPOLYMER TECHNOLOGY SYSTEMS, INC.JGY2022-04-11
08809115905406CURO L5 MeterOSANG HEALTHCARE Co., Ltd.JGY2021-07-09
08809115905444CURO L5 TG test stripOSANG HEALTHCARE Co., Ltd.JGY2021-06-17
00381934721019CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ctPOLYMER TECHNOLOGY SYSTEMS, INC.JGY2021-02-08
00381934722016CardioChek Plus Home Lipid Panel Self-Test Strip 2ctPOLYMER TECHNOLOGY SYSTEMS, INC.JGY2021-02-08