(29 days)
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No
The device description details a standard immunochemical chromatographic method for detecting hCG, which relies on chemical reactions and visual interpretation of lines. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No
The device aids in the detection of early pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or prevent any condition.
Yes
The device is described as an "in vitro diagnostic medical device" and its intended use is to aid in the detection of early pregnancy, which falls under the definition of a diagnostic purpose.
No
The device description clearly outlines a physical test stick with absorbent material, reagents, and a chromatographic strip, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy." This involves testing a biological sample (urine) to gain information about a physiological state (pregnancy).
- Device Description: The description clearly states, "The TBD Pregnancy Test is a Class II in vitro diagnostic medical device product." This is a direct classification of the device as an IVD.
- Mechanism: The device functions by an "immunochemical chromatographicchromogenic method in detecting the presence of hCG in the urine." This is a common method used in IVD tests to analyze biological samples.
- Sample Type: The test uses urine, which is a biological sample.
- Result Interpretation: The results are based on the presence or absence of a substance (hCG) in the urine, providing diagnostic information.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TBD Pregnancy Test is a simple-to-use, at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy.
Product codes
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Device Description
The TBD Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of an immunochemical chromatographicchromogenic method in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, housing an absorbent material that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by dipping the device into a container of urine for 20 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG in the urine sample (pregnant) is indicated by the appearance of two pink lines in the result window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
lay consumers, at-home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance studies conducted included the evaluation of the laboratory accuracy of the TBD test and the ability of lay consumers to perform the test and interpret the result. Two laboratory studies were conducted to determine the performance of the TBD test in comparison to the predicate device, CLEARBLUE Easy™ test. A third laboratory study was performed to evaluate and confirm the sensitivity of the TBD test. In two separate studies. the ability of consumers to perform and interpret the TBD Pregnancy Test was evaluated.
Key Metrics
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Predicate Device(s)
CLEARBLUE EASY™ One-Step Pregnancy Test
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
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May 1 , 1996 Page 14
| MAY 31 1996 | 510(k) SUMMARY |
|---|---|
| Submitted By: | Carter-Wallace |
| Carter Products Division | |
| P.O. Box 1001, Half Acre Road | |
| Cranbury, New Jersey 08512-0181 | |
| (609) 655-6000 | |
| Contact Person: | Maureen Garner |
| Date Prepared: | May 1, 1996 |
| Name of Device: | At-home Pregnancy Test |
| Classification Name: | Human chorionic gonadotropin (HCG) test system |
| Predicate Device: | CLEARBLUE EASY™ One-Step Pregnancy Test |
Description of the Device: The TBD Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of an immunochemical chromatographicchromogenic method in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, housing an absorbent material that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by dipping the device into a container of urine for 20 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG in the urine sample (pregnant) is indicated by the appearance of two pink lines in the result window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
The TBD Pregnancy Test is substantially equivalent to CLEARBLUE™ Easy One-Step Pregnancy Test manufactured by Whitehall Laboratories, Inc.
Intended Use of the Device: The TBD Pregnancy Test is a simple-to-use, at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy.
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III. 510(k) SUMMARY (cont'd)
Technological Characteristics: The TBD Pregnancy Test has similar technological characteristics as the predicate device although it differs from the predicate device in the type of direct label used to visualize the immunoreaction that indicates the presence of hCG. The TBD test uses colloidal gold which upon agglutination optically produces a pink color. The CLEARBLUE Easy™ device uses blue latex beads which upon agglutination produces a blue color. This difference has no technological significance other than to vield a pink-topurple result line in the subject device and to yield a blue result line in the predicate device. The TBD test also differs in that it utilizes a third complexing reaction to enhance and produce the easy-to-read test result. These minor technological differences raise no new issues regarding safety or effectiveness.
The performance studies conducted included the evaluation of the laboratory accuracy of the TBD test and the ability of lay consumers to perform the test and interpret the result. Two laboratory studies were conducted to determine the performance of the TBD test in comparison to the predicate device, CLEARBLUE Easy™ test. A third laboratory study was performed to evaluate and confirm the sensitivity of the TBD test. In two separate studies. the ability of consumers to perform and interpret the TBD Pregnancy Test was evaluated.