(62 days)
AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.
This document describes the acceptance criteria and study proving the performance of the AimStep™ Pregnancy (Home Test).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection of hCG at 20 mIU/ml and greater | The AimStep™ Pregnancy test detects hCG concentrations of 20 mIU/ml and greater. |
| No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) | The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity. |
| Accuracy (Correlation with predicate device) | Over 99% correlation between AimStep™ Pregnancy and the Clearview™ Easy HCG Pregnancy Test. |
| Ease of use and clear instructions for non-professional users | The majority of participants found AimStep™ Pregnancy very easy to use, and had no trouble understanding the labeling, reading the instructions, or interpreting the results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 137 female participants.
- Data Provenance: The document does not explicitly state the country of origin. It is a "clinical trial," which implies prospective data collection, but this is not explicitly confirmed. Given the context of a 510(k) submission to the FDA, it is highly likely the study was conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The comparison was made against a predicate device (Clearview™ Easy HCG Pregnancy Test), which itself is a legally marketed device for pregnancy determination. The results of the predicate device served as the reference for comparison.
4. Adjudication Method for the Test Set
Not applicable. The study compared the device's results directly to a predicate device, not against an adjudicated ground truth from multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the performance of the device against a predicate device, not on the improvement of human readers with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted in the sense that the AimStep™ Pregnancy device was evaluated on its own ability to detect hCG and its correlation with a predicate device. The accuracy of detecting hCG at 20 mIU/ml and greater, and the lack of cross-reactivity, represent standalone performance metrics.
7. Type of Ground Truth Used
The ground truth for the clinical trial was established by the results of the legally marketed predicate device, the Clearview™ Easy HCG Pregnancy Test. This implies a "device-to-device comparison" ground truth where the established accuracy of the predicate device is assumed to be the truth for the purpose of comparison. The primary function of the test is for "identification of hCG," and its ability to detect specific concentrations and show no cross-reactivity suggests a chemical/biological assay's intrinsic truth as well.
8. Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. The description of the device's performance (e.g., detection limit, cross-reactivity) suggests laboratory testing and standardization, which would involve samples, but these are not referred to as a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the context of machine learning is not described. The device's performance characteristics (detection limit, cross-reactivity) would have been established through laboratory experiments and standardization to the World Health Organization Third International Standard, which serves as a definitive reference for hCG measurement.
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JAN 2 2 2002
"Summary of Safety & Effectiveness"
The AimStep™ Pregnancy (Home Test) is intended for non-professional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.
The AimStep™ Pregnancy icst detects hCG concentrations of 20 mlU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hI.II (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µ1U/ml) to negative (0 mIJ/ml hCG) and positive (20 mlU/ml h(.C) urine showed no cross-reactivity.
A clinical trial was conducted comparing the results of AimStep™ Pregnancy to the Clearview™ Easy HCG Pregnancy Test. The study included 137 female participants and demonstrated an accuracy of over 99% correlation between the 2 tests. The results also showed that the majority of the participants found AimSten™ Pregnancy very casy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.
AimStep™ Pregnancy and the Clearvicw™ Easy 11CG Pregnancy Test use the following similar methodologies and components:
- a) Dry particle coated with anti-hCCi which reacts with the specimen
- b) Specimen migrates on a membrane coated with antibodies
- c) A colored line appears in a Test Region to indicate a positive result
- d) A colored line appears in a Control/Reference Region to indicate the test is completed and has worked correctly
AimStep™ Pregnancy and Clearview™ Easy HCG Pregnancy Test use the following different methodologies and components:
- a) AimStep™ Pregnancy uses a colloidal gold particle and the predicate device uses a blue latex particle
- b) AimStep™ Pregnancy produces a Pink colored line in the Test and Control Zones and the predicativ device produces a Blue colored line in the Test and Reference region.
The overall results of the clinical trial confirm that AirnStep™ Pregnancy (Home Test for over the counter pregnancy testing
Martin O'Connor, Regulatory Affairs
Date
Premarket Notification 510(k) Number
Paqe 】 uf 77
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and left side of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Martin O'Connor Regulatory Affairs Germaine Laboratories, Inc. 4139 Gardendale Center, Suite 101 San Antonio, TX 78229
JAN 2 2 2002
K013857 Trade/Device Name: AimStep™ Pregnancy Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: November 20, 2001 Received: November 21, 2001
Dear Mr. O'Connor:
Re:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 11 you dolly 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Usc
510(k) Number: K013857
Device Name: AimStep™ Pregnancy
"Indications For Use" -
AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
Can Coope
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013857
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Prescription Use (pcr 21 CFR 801.109)
Over-The-Counter Use
3 at 21 િત્તવૃદ્ય
§ 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.