(30 days)
Unotech AccuTest™ hCG-Urine
Unotech AccuTest™ hCG-Urine
No
The summary describes a qualitative immunoassay for pregnancy detection, which is a chemical-based test and does not involve AI/ML. There are no mentions of AI, ML, image processing, or complex algorithms.
No.
The device is used for the qualitative determination of hCG in urine for early detection of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
This device is for the "qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy," which is a diagnostic purpose.
No
The device description is not provided, but the intended use and performance studies clearly indicate a physical test strip for detecting hCG in urine, not a software-only device.
Yes, based on the provided information, the Unotech AccuStrip hCG-Urine is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy." This clearly describes a test performed in vitro (outside the body) on a biological sample (urine) to provide diagnostic information (pregnancy detection).
- Sample Type: The device uses "human urine," which is a biological specimen.
- Testing Location: The intended users are "physicians' office laboratories and clinical laboratories," which are typical settings for performing in vitro diagnostic tests.
- Performance Studies: The description of performance studies involves testing "urine specimens" and evaluating the device's ability to detect hCG levels, which are characteristic of IVD performance evaluation.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Unotech AccuStrip hCG-Urine fits this definition perfectly.
N/A
Intended Use / Indications for Use
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.
Product codes
JHI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians' office laboratories and clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A multicenter clinical study was conducted in three physicians' offices laboratories.
Sample Size: A total of 208 urine specimens were tested.
Data Source: Clinical subjects included female patients seeking confirmation of pregnancy, those who were confirmed pregnant, and 19 post-menopausal women.
Annotation Protocol: Urine samples with hCG concentrations of 0, 25, 50, 10°, 104, 105, 5x105 and 106 mIU/mL were tested in a separate experiment to evaluate sensitivity.
Summary of Performance Studies
Study Type: Multicenter clinical study and sensitivity evaluation.
Sample Size: 208 urine specimens for the clinical study; 90 samples (10 at each of 9 hCG concentrations) for the sensitivity study.
Key Results: The Unotech AccuStrip™ hCG-Urine had 100% agreement with the Unotech AccuTest™ hCG-Urine in the clinical study (89 positive, 110 negative). The sensitivity study demonstrated 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.
Key Metrics
Agreement: 100% with predicate device (Unotech AccuTest™ hCG-Urine).
Detection Limit: as low as 25 mIU/mL and as high as 1,000,000 mIU/mL.
Predicate Device(s)
Unotech AccuTest™ hCG-Urine
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 220 | |
| San Leandro, CA 94577 | |
| Contact Person: | Ken Wu, Ph.D. |
| President | |
| Phone: (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.
| | Unotech
AccuStrip™ hCG-Urine | Unotech
AccuTest™ hCG-Urine |
|----------|---------------------------------|--------------------------------|
| Positive | 89 | 89 |
| Negative | 110 | 110 |
3s
1
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.
2
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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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Page 2
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
4
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)