(45 days)
CHOICE accu-test™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for overthe-counter use.
CHOICE accu-test™ detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by two colored lines in the window. The absence of hCG produces only one colored line in the window.
Here's a breakdown of the acceptance criteria and study information for the CHOICE accu-test™ One-Step Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Specificity | >99% acceptance | >99% |
| Sensitivity | >99% acceptance | >99% |
| Accuracy | >99% acceptance | >99% |
| Interfering Substances | >99% acceptance | >99% |
| Stability Studies | >99% acceptance | >99% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 132 test devices were compared.
- Data Provenance: Not explicitly stated whether retrospective or prospective. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic for a clear biological marker (hCG), and the ground truth would be established by the presence or absence of hCG, likely via a laboratory reference method. The text does not mention the use of human experts for ground truth establishment in this context.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication is not mentioned for establishing ground truth for this type of test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is a comparison study against a predicate device, not an evaluation of human readers with vs. without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The device itself is a standalone diagnostic test, and the reported performance metrics (Specificity, Sensitivity, Accuracy) reflect its inherent performance in detecting hCG.
7. Type of Ground Truth Used
The ground truth used for the comparison study would have been the results obtained from the "SAS™ Serum/Urine hCG Pregnancy Test Kits," which served as the reference method. This indicates a comparison to a predicate/reference diagnostic method rather than expert consensus, pathology, or outcomes data. For an hCG test, the ground truth is ultimately the actual presence or absence of the hCG hormone.
8. Sample Size for the Training Set
The document does not mention a "training set" as this is a traditional in vitro diagnostic device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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510(K) SUMMARY
DEC 1 9 1997
510(k) Number:
Product Name:
Submitted by:
Contact:
2 114.00
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に、い
Classification:
Intended Use:
Description of Device:
Substantial Equivalence Devi
Clinical Reference Device:
Performance Data:
CHOICE accu-test™ One-Step Pregnancy Test
SA Scientific, Inc. 4919 Golden Quail San Antonio, TX, 78240
Mike Crisp Ph: (210) 699-8800 Fax: (210) 699-6545
Human chorionic gonadotropin (hCG) test system
Rapid one-step visual test for the qualitative detection of hCG in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.
CHOICE accu-test™ detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by two colored lines in the window. The absence of hCG produces only one colored line in the window.
Substantial Equivalence Device: Be Sure® Plus Pregnancy Test Kit
SAS™ Serum/Urine hCG Pregnancy Test Kit
Specificity, Sensitivity & Accuracy, Interfering Substances, and Stability Studies resulted in >99% acceptance. A Comparison Study of 132 test devices with SAS™ Serum/Urine hCG Pregnancy Test Kits resulted in >99% accuracy.
Date Originally Prepared:
October 31, 1997
Page 17
$\kappa = 27$
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 19 1997
Dr. Harbi Shadfan . President SA Scientific, Inc. 4919 Golden Quail San Antonio, Texas 78240
Re : K974154 CHOICE accu-test™ Pregnancy Test Kit Regulatory Class: II Product Code: LCX Dated: October 31, 1997 Received: November 4, 1997
Dear Dr. Shadfan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 additionally 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification™ (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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 Use
510(k) Number: None
Device Name: CHOICE accu-test™ Pregnancy Test Kit
"Indications For Use" -
CHOICE accu-test™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for overthe-counter use.
UMichael W. Anstrom
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974154
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
§ 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.