(30 days)
The intended use of the Unotech AccuStrip 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' office laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
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Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for AccuStrip™ hCG-Urine
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AccuStrip™ hCG-Urine device seem to be implicitly defined by its agreement with a predicate device (Unotech AccuTest™ hCG-Urine) and its ability to detect hCG at specific concentration ranges.
| Acceptance Criteria | Device Performance (AccuStrip™ hCG-Urine) |
|---|---|
| Clinical Agreement with Predicate Device (Unotech AccuTest™ hCG-Urine): | 100% agreement (89 positive, 110 negative) |
| Low-End hCG Detection: | Detects hCG at 25 mIU/mL (10/10 samples positive) |
| High-End hCG Detection: | Detects hCG at 1,000,000 mIU/mL (10/10 samples positive) |
| Specificity (0 mIU/mL hCG): | 0% positive (0/10 samples positive) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 208 urine specimens were tested for clinical comparison with the predicate device. For sensitivity testing, 10 samples were used at each of 9 different hCG concentrations (0, 25, 50, 10², 10³, 10⁴, 10⁵, 5x10⁵, and 10⁶ mIU/mL), totaling 90 samples.
- Data Provenance: The clinical study was conducted in "three physicians' office laboratories." The origin of the urine specimens is described as "Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, and 19 post-menopausal women," implying the data is from relevant patient populations, likely in the US where the physicians' offices are located. The study is prospective in the sense that the new device was tested on collected samples alongside the predicate. Clinical subjects are mentioned, suggesting a patient-derived dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth.
- For the clinical agreement study, the "ground truth" for the AccuStrip™ hCG-Urine was established by its agreement with the Unotech AccuTest™ hCG-Urine, which is the predicate device. It's assumed the predicate device itself provides an accepted standard.
- For the sensitivity study, the "ground truth" was based on known, spiked concentrations of hCG in urine samples.
4. Adjudication Method for the Test Set
No explicit adjudication method is described. For the clinical comparison, the primary method was direct agreement with the predicate device's results. For the sensitivity testing, the results were compared against known hCG concentrations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the AccuStrip™ hCG-Urine compared to another device and against known concentrations. It does not evaluate human readers' improvement with or without AI assistance, as this is a diagnostic test kit, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was conducted. The AccuStrip™ hCG-Urine is a diagnostic strip test, and its results are read directly, likely by a healthcare professional or lab technician. The studies described – clinical agreement and sensitivity testing – assess the performance of the device itself (the "algorithm" in a broad sense for a chemical test), independent of interpretive assistance for its users beyond the inherent design of the test.
7. The Type of Ground Truth Used
- For the clinical comparison, the ground truth was comparison to a predicate device (Unotech AccuTest™ hCG-Urine).
- For the sensitivity and specificity testing, the ground truth was known, manufactured concentrations of hCG in urine samples.
8. The Sample Size for the Training Set
The document does not mention a separate training set. This is typical for traditional diagnostic test kits that are developed through chemical and biological experimentation and validation, rather than machine learning algorithms which require training data. The "studies" described are validation studies.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this question is not applicable.
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K981/838
510(k) Notification Unotech Diagnostics Inc. AccuStrip™ hCG-Urine May 21, 1998
510(k) Summary of Safety and Effectiveness Substantial Equivalence Discussion
| Trade or Proprietary Name: | AccuStrip™ 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 |
JUN 25 1998
We conducted a multicenter clinical study in three physicians' offices laboratories. We provided each site with the Unotech AccuStrip™ hCG-Urine and the Unotech AccuTest™ hCG-Urine.
A total of 208 urine specimens were tested in these physicians' office laboratories using both Unotech tests. Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, and 19 post-menopausal women.
The test results show that the Unotech AccuStrip™ hCG-Urine has 100% agreement with the Unotech AccuTest™ hCG-Urine.
| UnotechAccuStrip™ hCG-Urine | UnotechAccuTest™ hCG-Urine | |
|---|---|---|
| Positive | 89 | 89 |
| Negative | 110 | 110 |
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The following experiments were carried out to evaluate the sensitivity of AccuStrip™ hCG-Urine at low end and high end levels of hCG. Urine samples with hCG concentrations of 0, 25, 50, 10°, 104, 105, 5x105 and 106 mIU/mL were tested. The results are presented below.
| hCG (mIU/mL) | 0 | 25 | 50 | 102 | 103 | 104 | 105 | 5x105 | 106 |
|---|---|---|---|---|---|---|---|---|---|
| # of samples | 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 |
The results demonstrate that the Unotech AccuStrip™ 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 AccuStrip™ hCG-Urine Test is substantially equivalent to the AccuTest™ hCG-Urine Test.
The intended use of the Unotech AccuStrip™ 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' office laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 25 1998
Ken Wu, Ph.D. · President Unotech Diagnostics, Inc. 2235 Polvorosa Avenue, Suite 220 San Leandro, California 94577
K981838 Re : Unotech AccuStrip™ hCG-Urine Regulatory Class: II Product Code: JHI Dated: May 21, 1998 May 26, 1998 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. प्र substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 requlations.
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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.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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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Page 1 of 1 __
510(k) Number (if known):__N/A
Device Name: AccuStrip hCG-Urine
Indications For Use:
The intended use of the Unotech AccuStrip 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' office laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.
(Division Sign-Off)
Division of Clinical Laboratory Devicez
510(k) Number
198
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
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.