(112 days)
The MySet™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Over-The-Counter Use.
The MySet™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The MySet™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test employs a unique combination of monoclonal-dye conjugate and mouse monoclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a red color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a red color band, demonstrating that the test is functioning correctly.
The MySet™ Pregnancy Test is a device designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine, intended for the early detection of pregnancy for Over-The-Counter Use.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (MySet™ Pregnancy Test) |
|---|---|
| Substantial equivalence to a legally marketed predicate device (Stanbio True® 20 One-Step Pregnancy Test - K980531) | 100% Agreement with Stanbio True® 20 One-Step Pregnancy Test |
| Detect hCG in urine at a concentration level of 25 mIU/ml | Detects hCG in urine at a concentration level of 25 mIU/ml (inherent in intended use and technology) |
| User-friendliness for untrained individuals | Confirmed that "test can be effectively performed by untrained individuals" (women of childbearing years) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "A method comparison was done," but does not provide the number of samples or subjects included in this comparison.
- Data Provenance: Not explicitly stated regarding country of origin. The study was a "method comparison" against an FDA-cleared device. It is a retrospective comparison as it compares to an already cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth for the method comparison study was established by the performance of an existing, FDA-cleared predicate device (Stanbio True® 20 One-Step Pregnancy Test). No human experts were involved in establishing the ground truth beyond the initial validation of the predicate device.
4. Adjudication Method for the Test Set:
- Not applicable. The comparison was directly against the results of the predicate device. There was no mention of an adjudication process for discrepancies, likely due to the reported 100% agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted as described in the provided text. The study focused on a direct comparison of the device's performance against a predicate device, not on the impact of AI assistance on human readers.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, the performance data presented is for the standalone device, the MySet™ Pregnancy Test. The comparison was between the MySet™ device and the Stanbio True® 20 device operating independently. There is no indication of a human-in-the-loop component in the performance evaluation beyond the general user-friendliness testing by untrained women.
7. The Type of Ground Truth Used:
- The ground truth for the performance study was established by the results obtained from a legally marketed and FDA-cleared predicate device, the Stanbio True® 20 One-Step Pregnancy Test. This is a form of comparative ground truth where the performance of the new device is measured against a well-established and accepted standard. The predicate device itself would have been validated against a clinical ground truth (e.g., confirmed pregnancy via clinical assessment or other laboratory methods).
8. The Sample Size for the Training Set:
- Not applicable. This device is a manual, immunoassay-based pregnancy test, not an AI/algorithm-driven device that requires a training set in the computational sense. The "training" in this context refers to the manufacturing and formulation of reagents and device components.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as this is not an AI/algorithm-driven device. The "ground truth" during product development would involve verifying the accuracy and sensitivity of the reagents and components to detect 25 mIU/ml hCG, likely through spiked urine samples or clinically confirmed pregnancy samples. The document states the device "employs a unique combination of monoclonal-dye conjugate and mouse monoclonal-solid phase antibodies," implying a biochemical design and manufacturing process, not an algorithmic training process.
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K 053/38
MAR I 2006
510 (k) SUMMARY
Date of Summary: February 24, 2006
Product Name:
MySet™ Pregnancy Test
Sponsor:
Ani Biotech Oy Tiilitie 3, 01720 Vantaa, Finland
Correspondent:
MDC Associates Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915 (978)-927-3808
Substantially Equivalent Devices: Product: True® 20 One-Step Pregnancy Test Manufactured by: Stanbio Laboratory
PRODUCT DESCRIPTION:
The MySet™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The MySet™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml.
INTENDED USE:
The MySet™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Over-The-Counter Use.
SUMMARY OF TECHNOLOGY:
The One-Step Pregnancy Test employs a unique combination of monoclonal-dye conjugate and mouse monoclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a red color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a red color band, demonstrating that the test is functioning correctly.
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PERFORMANCE DATA:
A method comparison was done to compare the performance of the MySet™ Pregnancy Test to a FDA cleared product. These data clearly demonstrate the performance of the MySet™ Pregnancy Test by Ani Biotech Oy is substantially equivalent to a commercially available FDA cleared pregnancy test: Stanbio True® 20 One-Step Pregnancy Test (K980531)
Agreement: 100%
STATEMENT OF SAFETY AND EFFICACY:
The MySet™ Pregnancy Test when compared with another commonly used pregnancy test (Stanbio True 20-K980531) demonstrated 100% performance.
These data clearly demonstrate the safety and efficacy of the MySet™ Pregnancy Test and further confirm that the accuracy of this product when compared to a substantially equivalent device currently being sold.
Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted in a minimalist, abstract design.
Public Health Service
MAR I 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20130
Ani Biotech Ov c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
Re: K053138
Trade/Device Name: MySet™ Pregnancy Test Regulation Number: 21 CFR8862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: January 14, 2006 Received: January 17, 2006
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053138
MySet™ Pregnancy Test Device Name:
The MySet™ Pregnancy Test is a test for the qualitative Indications For Use: determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-the-Counter Use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Division Sign-Off | |
|---|---|
| Office of In Vitro Diagnostic Device | |
| K053138 |
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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.