(20 days)
The intended use of the Unotech AccuTest hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. We intend to market this product to physicians' offices laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
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The Unotech Diagnostics Inc. AccuTest™ hCG-Urine is a Human Chorionic Gonadotropin Test System intended for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. The device aims to achieve 100% agreement with a legally marketed predicate device (Abbott TestPack Plus™ hCG-COMBO) in clinical settings and demonstrate its ability to detect hCG across a specific concentration range.
Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance Statement | Value |
|---|---|---|
| Clinical Agreement: 100% agreement with the Abbott TestPack Plus™ hCG-COMBO test. | "The test results show that the Unotech AccuTest™ hCG-Urine has 100% agreement with the Abbot TestPack Plus™ hCG-COMBO." | 100% |
| Analytical Sensitivity (Low End): Detection of hCG at 25 mIU/mL. | "The results demonstrate that the Unotech AccuTest™ hCG-Urine Test can detect hCG in urine at levels as low as 25 mIU/mL..." In the sensitivity table, all 10 samples at 25 mIU/mL were reported positive. | 100% detection at 25 mIU/mL |
| Analytical Sensitivity (High End): Detection of hCG at 1,000,000 mIU/mL (10^6^ mIU/mL). | "...and as high as 1,000,000 mIU/mL." In the sensitivity table, all 10 samples at 10^6^ mIU/mL were reported positive. | 100% detection at 1,000,000 mIU/mL |
| Analytical Specificity (0 mIU/mL hCG): No false positives at 0 mIU/mL hCG. | In the sensitivity table, at 0 mIU/mL hCG, 0 samples were positive and 10 were negative. | 0% false positives at 0 mIU/mL |
The summary table explicitly states the 100% agreement for the clinical study. For the analytical sensitivity, the text and the accompanying table confirm detection across the specified range, including 25 mIU/mL and 1,000,000 mIU/mL, as well as accurate negative results at 0 mIU/mL.
2. Sample size used for the test set and the data provenance
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Sample Size for Clinical Study: 197 urine specimens.
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Data Provenance: The study was a multicenter clinical study conducted in three physicians' offices laboratories. The clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, and 8 post-menopausal women. This indicates the data is prospective and originated from clinical settings in the USA.
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Sample Size for Analytical Sensitivity Study: For each hCG concentration level (0, 25, 50, 10^2^, 10^3^, 10^4^, 10^5^, 5x10^5^, 10^6^ mIU/mL), 10 samples were tested. This totals 90 samples for the analytical sensitivity testing.
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Data Provenance for Analytical Sensitivity Study: The provenance of these specifically spiked samples is not explicitly stated but is implicitly a controlled laboratory setting, performed by Unotech Diagnostics Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
However, the "ground truth" for the clinical agreement study was established by the Abbott TestPack Plus™ hCG-COMBO, which is a legally marketed predicate device. This implies that the predicate device's results were considered the reference standard for comparison. For the analytical sensitivity study, the ground truth was established by the known concentrations of hCG in the spiked urine samples.
4. Adjudication method for the test set
The provided text does not mention any adjudication method (e.g., 2+1, 3+1) for the test set. The comparison for the clinical study was directly against the results of the predicate device, the Abbott TestPack Plus™ hCG-COMBO. For the analytical study, it was a direct comparison to known hCG concentrations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test (a chemical assay), not an AI-assisted diagnostic, so the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone, qualitative diagnostic test (AccuTest™ hCG-Urine). The performance described in the document is the standalone performance of the device (without human-in-the-loop interaction beyond performing the test according to instructions). It's a chemical test, not an algorithm.
7. The type of ground truth used
- For the Clinical Study: The ground truth was established by the results of a legally marketed predicate device, the Abbott TestPack Plus™ hCG-COMBO. Additionally, the clinical subjects included "female patients seeking confirmation of pregnancy" and "those who were confirmed pregnant," implying that the clinical status (confirmed pregnancy or not) also served as a form of ground truth for assessing the test's agreement with the predicate.
- For the Analytical Sensitivity and Specificity Study: The ground truth was based on known, pre-defined concentrations of hCG in urine samples (0, 25, 50, etc., mIU/mL).
8. The sample size for the training set
This device is not an AI/ML algorithm that requires a "training set." It is a chemical diagnostic test. Therefore, the concept of a training set is not applicable.
9. How the ground truth for the training set was established
As explained in point 8, the concept of a training set is not applicable to this type of chemical diagnostic device.
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510(k) Notification Unotech Diagnostics Inc. AccuTest™ hCG-Urine May 21, 1997
510(k) Summary of Safety and Effectiveness Substantial Equivalence Discussion
| Trade or Proprietary Name: | AccuTest™ hCG-Urine |
|---|---|
| Common or Usual Name: | Human Chorionic Gonadotropin Test System |
| Product Classification No.: | 21 CFR §862.1155, Class II |
| Manufacturer: | Unotech Diagnostics Inc.2235 Polvorosa Avenue, Suite 220San Leandro, CA 94577 |
| Contact Person: | Ken Wu, Ph.D.PresidentPhone: (510) 352-3070 |
We conducted a multicenter clinical study in three physicians' offices laboratories. We provided each site with the Unotech AccuTest™ hCG-Urine and the Abbott TestPack Plus™ hCG-COMBO.
A total of 197 urine specimens were tested in these physicians' offices laboratories using both Unotech and Abbott tests. Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, and 8 post-menopausal women.
The test results show that the Unotech AccuTest™ hCG-Urine has 100% agreement with the Abbot TestPack Plus™ hCG-COMBO.
| UnotechAccuTest™ hCG-Urine | AbbottTestPack Plus™ hCG-COMBO | |
|---|---|---|
| Positive | 70 | 70 |
| Negative | 127 | 127 |
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The following experiments were carried out to evaluate the sensitivity of AccuTest™ hCG-Urine at low end and high end levels of hCG. Urine samples with hCG concentrations of 0, 25, 50, 10', 10', 104, 105, 5x105 and 106 mIU/mL were tested. The results are presented below. 27
| hCG (mIU/mL) | 0 | ટેટ | રે રેણે રહ્યા છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ | 102 | 5x105 106 1 | 1 min | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| # of samples | 10 | 10 | 10 - | 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - | 10 | 10 | 10 | 10 | 10 | |
| Positive | 0 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | |
| Negative | 10 | 0 | 0 0 0 0 0 0 0 | 0 0 | 0 | 0 |
The results demonstrate that the Unotech AccuTest™ hCG-Urine Test can detect hCG in urine at levels as low as 25 mIU/mL and as high as 1,000,000 mIU/mL.
These results establish that the Unotech AccuTest™ hCG-Urine Test is substantially equivalent to the Abbott Test Pack Plus™ hCG-COMBO Test.
The intended use of the Unotech AccuTest™ hCG-Urine is for the early detection of pregnancy by the qualitative determination of human chorionic gonadotropin (hCG) in human urine. Our intent is to market this product to physicians' offices laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN | | 1997
Ken Wu, Ph.D. President Unotech Diagnostics Inc. . 2235 Polvorosa Avenue, Suite 220 San Leandro, California 94577
Re : K971886 Unotech AccuTest™ hCG-Urine Requlatory Class: II Product Code: JHI Dated: May 21, 1997 May 22, 1997 Received:
Dear Dr. Wu:
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 Requlations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the Good Manufacturing Fractice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 requlation (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.gov/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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(k) Number (if known): ___K971886
ice Name:__AccuTest hCG-Urine
cations For Use: _
me intended use of the Unotech AccuTest hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy. We intend to market this product to physicians' offices laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| Division of Clinical Laboratory Devices |
510(k) Number__
OR
Prescription Use_V Per 21 CFR 801.109)
Ove
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.