(34 days)
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No
The device description details a simple immunochemical test with visual interpretation of results based on the appearance of lines. There is no mention of any computational analysis, algorithms, or learning processes.
No.
The device is an in vitro diagnostic test for detecting pregnancy, not for treating a disease or condition.
Yes
The device is described as a "Class II in vitro diagnostic medical device product" and its intended use is for "detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy", directly indicating its diagnostic purpose.
No
The device description clearly outlines a physical test stick with an absorbent pad, chromatographic strip, and reagents, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy." This is a diagnostic purpose performed on a sample taken from the body (urine).
- Device Description: The description details an "immunochemical chromatographic-chromogenic method" for detecting a substance (hCG) in a biological sample (urine). This is a common method used in in vitro diagnostics.
- Classification: The description explicitly states it is a "Class II in vitro diagnostic medical device product."
All of these points clearly indicate that the Brand Name 1-Step Pregnancy Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Brand Name 1-Step 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 Brand Name 1 -Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of an immunochemical chromatographic-chromogenic 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 pad that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent pad of the device in the urine stream for 5 seconds or by dipping the device into a container of urine for 5 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 test 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
One-Step CLEARBLUE Easy™ Pregnancy Test
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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.
0
510(k) SUMMARY
UL 10 1996
| 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: | June 5, 1996 |
| Name of Device: | Brand Name 1-Step Pregnancy Test |
| Classification Name: | Human chorionic gonadotropin (hCG) test system |
| | |
Predicate Device: One-Step CLEARBLUE Easy™ Pregnancy Test
The Brand Name 1 -Step Pregnancy Test is a Class II in vitro Description of the Device: diagnostic medical device product that functions by way of an immunochemical chromatographic-chromogenic 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 pad that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent pad of the device in the urine stream for 5 seconds or by dipping the device into a container of urine for 5 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 test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
The Brand Name 1-Step Pregnancy test is substantially equivalent to the One Step CLEARBLUE™ Easy Pregnancy test distributed by Whitehall Laboratories, Inc.
Intended Use of the Device: The Brand Name 1-Step 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.