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510(k) Data Aggregation
K Number
K251053Device Name
Shinetell PlusTM Digital Early Pregnancy Test
Manufacturer
Hangzhou AllTest Biotech Co., Ltd.
Date Cleared
2025-07-15
(102 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250117Device Name
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
Manufacturer
Assure Tech LLC
Date Cleared
2025-02-13
(28 days)
Product Code
LCX, JHI
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FaStep Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. For over-the-counter use.
The Fastep HCG Rapid Test Cassette is a rapid visual immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs).
Device Description
The FaStep Pregnancy Rapid Test Cassette and the Fastep HCG Rapid Test Cassette are the same device with the first intended for over-the counter use and the second for prescription use. The devices contain individually wrapped pouches containing the device, instructions for use, and pipette droppers.
The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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K Number
K242135Device Name
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
Manufacturer
Nanjing Synthgene Medical Technology Co., Ltd.
Date Cleared
2025-01-31
(193 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthgene Home Test HCG Test Midstream is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthqene Home Test HCG Test Cassette is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Synthqene Home Test HCG Test Strip is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
Device Description
Synthgene Home Test HCG Test is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains the individually packaged test pen/strip/cassette, medical waste bag, urine cup and instructions for Use. The cassette format also contains a dropper. The device is in a readyto-use format and does not require assembly before use.
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K Number
K243573Device Name
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
Manufacturer
Assure Tech LLC
Date Cleared
2025-01-15
(57 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FaStep Early Pregnancy Rapid Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use.
FaStep Early Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use.
FaStep Early Pregnancy Rapid Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For overthe-counter use.
Device Description
FaStep Early Pregnancy Rapid Test will be sold in Strip, Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode.
FaStep Early Pregnancy Rapid Test Strip, FaStep Early Pregnancy Rapid Test Cassette and FaStep Early Pregnancy Rapid Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper.
The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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K Number
K241394Device Name
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
Manufacturer
Andon Health Co., Ltd.
Date Cleared
2024-12-20
(218 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period.
The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period.
Device Description
The iHealth® Early Pregnancy Test is a lateral flow immunoassay technique device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and is indicated for use as an aid in early detection of pregnancy. The iHealth® Early Pregnancy Test is designed to detect as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period. Test result is displayed to the user as two lines for a 'Pregnant' result and one line for a 'Not Pregnant' result.
The iHealth® Early Pregnancy Test are in two different formats: Stick and Strip format. Two test formats use identical strips and each test strip in the device consists of: Sample pad, colloidal gold binding pad, nitrocellulose membrane, absorbent paper and PVC board, colloidal gold binding pad coated with hCG monoclonal antibody 1, test line(T Line) coated with hCG-monoclonal antibody 2 and control line(C Line) coated with goat anti-mouse IgG antibody.
Two formats have the same performance specifications. The difference is that Stick format is designed to be tested in dip or midstream method, and Strip format is tested in dip method only.
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K Number
K240242Device Name
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
Manufacturer
Anhui DEEPBLUE Medical Technology Co. LTD.
Date Cleared
2024-10-11
(255 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test strip is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
Device Description
The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) utilize a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The detection method is to observe the formation of colored lines when testing urine samples with test devices. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region if the test has been performed properly. HCG Pregnancy Test will be sold in three different formats: Cassette, Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and an Instruction. The Cassette format contains a test device, a dropper, a collection container and an Instruction. The test uses two red lines to indicate results. Two distinct red lines appear in the control region (C) and test region (T) means the test is "positive". Only one red line appears in the control region(C). No apparent line in the test region (T). means the test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.
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K Number
K241978Device Name
Shinetell Digital Pregnancy Test
Manufacturer
Hangzhou AllTest Biotech Co., Ltd.
Date Cleared
2024-08-13
(39 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.
Device Description
Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format. Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.
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K Number
K240643Device Name
MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
Manufacturer
Guangzhou Decheng Biotechnology Co., Ltd.
Date Cleared
2024-06-21
(106 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This device is intended for home-use only.
MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This device is intended for home-use only.
MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.
Important note regarding positive results:
Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.
This device is intended for home-use only.
Device Description
MissLan® Early Detection Pregnancy Test will be sold in Strip. Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode.
MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup.
The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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K Number
K232715Device Name
Distinct® Digital Pregnancy Test
Manufacturer
ACON Laboratories, Inc.
Date Cleared
2024-05-31
(269 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Distinct® Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid for the early detection of pregnancy. This test can help determine if you are pregnant as early as 6 days before the day of the missed period (5 days before the day of your expected period).
Device Description
Not Found
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K Number
K233624Device Name
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
Manufacturer
Hangzhou Aichek Medical Technology Co., Ltd.
Date Cleared
2024-04-12
(151 days)
Product Code
LCX, JHI
Regulation Number
862.1155Why did this record match?
Product Code :
LCX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The hCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The hCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The hCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
The hCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
Device Description
The tests are rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by added urine sample and obtaining the result from the colored lines.
The tests will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic card, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum foil pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum foil pouch, Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
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