FDA.reportPublic FDA data

PTS Panels Metabolic ChemistryTest Strips (15-ct)

Primary DI
00381932400015
Brand
PTS Panels Metabolic ChemistryTest Strips (15-ct)
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
2400
Catalog number
2400
Device description
PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monitor glucose; HDL cholesterol; and triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer.
Published
2016-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
JGYCOLORIMETRIC METHOD, TRIGLYCERIDES
LBRLDL & VLDL PRECIPITATION, HDL
NAQLIPOPROTEIN, HIGH DENSITY, HDL, OVER THE COUNTER
NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
NGOTEST, TRIGLYCERIDES, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JGYColorimetric Method, TriglyceridesClinical Chemistry1
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1
NAQLipoprotein, High Density, Hdl, Over The CounterClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
NGOTest, Triglycerides, Over The CounterClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070017000PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPSPolymer Technology Systems, Inc.2007-01-31NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381932400015PrimaryGS10
10381932400012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381932400015003819324000153819324000150381932400015
1038193240001210381932400012

GMDN Terms#

Term, Definition table
TermDefinition
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used together to produce a profile consisting of one or multiple clinical chemistry analytes which may include glucose, ketones and/or a lipid profile, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight Keep dry
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep away from sunlightKeep dry
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature20 Degrees Celsius28 Degrees Celsius
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature68 Degrees Fahrenheit82 Degrees Fahrenheit
Storage Environment Temperature68 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)870-5610customerservice@ptsdiagnostics.com
+1(888)877-5610customerservice@ptsdiagnostics.com
+1(877)870-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
15
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00381930737014A1CNow+ Controls™ Levels 1+27377372019-11-15
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

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