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510(k) Data Aggregation
K Number
K971286Device Name
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1997-05-08
(31 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZESure™ (Excel) Urine Midstream Early Pregnancy Home Test is Excel Scientific, Inc.'s device for OTC use of EZ Sure™ (Excel) Urine Midstream Early Pregnancy Home Test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.
Device Description
The EZ Sure™ (Excel) Urine Midstream Pregnancy Home Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. The stream of urine goes directly into the absorbent windows of the reaction device. The labeled antibody dye-conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the antibody in the positive reaction zone and produces a rose-pink color band when hCG concentration is equal to or greater than 25 mIU/mL. In the absence of hCG, there is no line formation in the positive reaction zone. The reaction mixture continues to flow through the device and migrates to the control reaction zone by producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.
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K Number
K970467Device Name
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1997-03-18
(39 days)
Product Code
CEP
Regulation Number
862.1485Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZYSure™ OneStep Ovulation Predictor Home Test Kit is Excel Scientific. Inc.'s name for OTC use of solld phase 1. immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine
Device Description
The EZY Sure™ OneStep Ovulation Prodictor Homo Test Kit is a sandwich solld phase dye-conjugato non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the LH in the specimen forming an antibody-antigen complex birds to the anti-LH antibody in the positive reaction zone and produces a rese pink color band when LH concentration is present in the abserve of LH, there is no rosepink line in the postive reaction cultinues to flow through the absorbent device, pass the positive reaction zurie, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.
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K Number
K970424Device Name
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1997-03-06
(30 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
qualitative detection of human phonic Gonadotropin (hCG) in urine.
Device Description
Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid Ekol of one of the more regioner in vitro diagnostic test kit for the qualitative detection of human phonic Gonadotropin (hCG) in urine. Excel OneStep Urine hCG Pregnancy DipStick Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of Excel OneStep Urine hCG Pregnancy DipStick Test is as follows:
- Both the Excel OneStep Urine hCG Pregnancy DipStick and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. tests are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the Excel OneStep Urine hCG Pregnancy DipStick is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary action. The gold sol-antibody conjugate in the gold sol pad of the Excel OneStep Urine hCG Pregnancy DipStick binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the white membrane area and produces a rose-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.
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K Number
K970425Device Name
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1997-03-06
(30 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZ > Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase L Four - Online Diponor Programo Tivitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.
Device Description
EZ > Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase L Four - Online Diponor Programo Tivitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.
The Principle of EZ&Sure™ Urine DipStick Pregnancy Home Test is as follows:
- Both the EZ\$ Sure™ Urine DipStick Pregnancy Home Test and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. boon the E2 Pour - Smo Dipease regiugated non-enzyme immunoassay. When the EZ \$ Sure™ Urine .o.&fick Pregnancy Home Test is placed in a urine test cup containing the urine specimen, the urine will Dipoton Prognanoy Profile Tothe Total Sol-antibody conjugate in the gold sol pad of the EZ \$ Sure™ Urine migrate by capillary active to the hCG molecules in the specimen forming an antibody-antigen Dipolon't roghano 110mle 100 the antibody immobilized in the positive reaction zone in the white complox. This complex a rose-pink color band when the hCG concentration is at or greater than 25 millione area and produces of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.
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K Number
K963231Device Name
EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1996-12-04
(107 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
qualitative determination of human chorionic gonadotropin in urine.
Device Description
solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine.
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K Number
K962146Device Name
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1996-10-07
(126 days)
Product Code
GTZ
Regulation Number
866.3740Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
qualitative detection of group A strep antigen from throat swabs
Device Description
solid phase migratory chromatography immunoassay in vitro diagnostic test kit
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K Number
K962580Device Name
EZ SURE ONESTEP EARLY PREGNANCY TEST
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1996-08-29
(59 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZ Sure OneStep Pregnancy Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine.
Device Description
EZ Sure OneStep Pregnancy Test is a sandwich solid phase dyeconjugated non-enzyme immunoassay. When the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the position zone in the viewing window and produces a purple-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no purple-pink band in the positive reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band in the control zone, demonstrating that the reagents and the device are functioning correctly.
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K Number
K955707Device Name
ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
Manufacturer
EXCEL SCIENTIFIC, INC.
Date Cleared
1996-05-02
(139 days)
Product Code
DHA
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
EXCEL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
qualitative determination of human chorionic gonadotropin in urine or serum.
Device Description
solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine or serum.
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