(20 days)
Not Found
Not Found
No
The summary describes a qualitative immunoassay for pregnancy detection, which is a standard chemical/biological test and does not mention any computational or learning-based components.
No.
The device is used for the "early detection of pregnancy," which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate any medical condition.
Yes
The device is described as being for "qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy," which is a diagnostic purpose.
No
The summary describes a device for detecting hCG in urine, which is a chemical test requiring a physical test strip or similar hardware component to interact with the urine sample. The description of performance studies involving testing urine specimens further supports this. There is no mention of software as the primary or sole component.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to diagnose a condition (pregnancy).
- Sample Type: The device uses human urine, which is a biological specimen.
- Testing Location: The intended users are "physicians' offices laboratories and clinical laboratories," which are typical settings for in vitro diagnostic testing.
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Unotech AccuTest hCG-Urine clearly fits this description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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' offices laboratories and clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 220 | |
| San Leandro, CA 94577 | |
| Contact Person: | Ken Wu, Ph.D. |
| President | |
| Phone: (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.
| | Unotech
AccuTest™ hCG-Urine | Abbott
TestPack Plus™ hCG-COMBO |
|----------|--------------------------------|------------------------------------|
| Positive | 70 | 70 |
| Negative | 127 | 127 |
1
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.
2
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.
3
Paqe 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 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
4
Page 1_ of 1_
(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)
| (Division Sign-Off) |
|---|
| 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)