FDA.reportPublic FDA data

A1CNow® Self Check Test System

Primary DI
00381933030013
Brand
A1CNow® Self Check Test System
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
3030
Catalog number
3030
Device description
The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Published
2016-08-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCPASSAY, GLYCOSYLATED HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090413000A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECBayer Healthcare, LLC2009-05-14LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381933030013PrimaryGS10
10381933030010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381933030013003819330300133819330300130381933030013
1038193303001010381933030010

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if dot is red or if the product is past the expiration date.
Special Storage Condition, Specify00Keep away from sunlight.
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature64 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
835772872
Device count
2
Kit
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978139074008H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074015H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074022H100Plus HbA1c Eluent BShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074039H100Plus HbA1c Eluent CShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074046H100Plus HbA1c CalibratorShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074053H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074060H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074077H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074084H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074381H100Plus Hemoglobin Analyzer(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074398H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074404H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06980120080356H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
00380740208622ARCHITECTAbbott GmbHLCP2026-05-15
00380740208639AlinityAbbott GmbHLCP2026-05-15
00860004423409QvinQurasense, Inc.LCP2026-05-08
00860004423492QvinQurasense, Inc.LCP2026-05-08
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONLCP2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONLCP2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONLCP2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONLCP2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONLCP2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONLCP2026-01-05
04713106028187URIGHT Hemoglobin A1c AnalyzerTAIDOC TECHNOLOGY CORPORATIONLCP2025-03-26