(57 days)
No
The device description details a standard chromatographic immunoassay (CIA) that relies on chemical reactions and visual interpretation of colored bands. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The performance studies also focus on the chemical and biological aspects of the test, not on algorithmic performance.
No
This device is designed for diagnostic screening (pregnancy detection), not for treating or alleviating a disease or condition.
Yes
The device is explicitly described as a "Home Pregnancy Test Device" intended for "qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy" and for "early pregnancy diagnosis," which are all diagnostic purposes.
No
The device description explicitly states it is a "colored solid-phase Chromatographic Immunoassay (CIA)" and is "provided as a test strip contained within a plastic test strip holding cassette," indicating it is a physical, hardware-based test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to provide diagnostic information (pregnancy status).
- Device Description: The description details a "solid-phase Chromatographic Immunoassay (CIA)" that detects hCG in urine. This is a common method used in IVD tests.
- Mechanism of Action: The description explains how the test works by detecting hCG in the urine specimen using antibodies and a visual indicator. This is characteristic of an IVD test that analyzes a biological sample for a specific analyte.
- Performance Studies: The document includes performance studies evaluating the device's sensitivity, accuracy, and specificity using urine specimens. This type of testing is required for IVD devices to demonstrate their performance characteristics.
- Predicate Devices: The mention of predicate devices (other hCG pregnancy tests) further indicates that this device falls within the category of IVDs.
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 purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The UniMark® Home Pregnancy Test Device is intended for the qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy.
UniMark® Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin (hCG) in urine. It is intended for consumer use at home.
It is indicated for use in the early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The UniMark® Home Pregnancy Test Device is a colored solid-phase Chromatographic Immunoassay (CIA) for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is a home use, rapid, visual, one step pregnancy screening test.
Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone synthesized by the placenta and released in blood and urine soon after the implantation of a fertilized ovum in the chorionic tissue. HCG is the principal signal and specific marker of the pregnancy. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies conjugated to colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat anti-hCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates the presence of an hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.
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
consumer use at home.
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
The UniMark® Home Pregnancy Test Device was evaluated in a consumer study of 100 home users selected on a random basis as they presented themselves at the offices or labs of the assigned organizers in central New Jersey and New York City. The home users represented a diverse ages, backgrounds, and educational levels.
Urine specimens from non-pregnant women were examined and mixed as an hCG-free specimen. The specimens were split into 4 fractions and spiked with hCG to the concentrations of 0, 20 (20% lower than 25 mIU/ml, the sensitivity level), 30 (20% higher than 25 mIU/ml) and 1000 mIU/ml. Each fraction was further split into dropping bottles. The bottles were labeled with codes. 4 pregnancy devices and one coded control set (0, 20, 30, 1000 mIU/ml) were placed into one bag as one study-kit.
The study was explained to the home users by the organizer or lab technician. If the home user agreed to participate, written and verbal instructions on how to perform the test were provided with one study-kit. The home user performed the test procedure for each of the four controls and read the results. At the conclusion of the test, each home user was asked to complete and sign a questionnaire to obtain feedback on the test. The home user marked the used devices with a control code and her name. The user test results were observed and verified by the organizer or lab assistant to verify correct interpretation of positive or negative. The form, the control set, and tested devices were put back into the plastic bag as a back-kit. All of the back-kits were sent back to Biotech Atlantic. The lab technician of Biotech Atlantic subsequently tested the set of coded controls in the back-kit from each home user with the professional (predicate) test (UniMark® hCG Pregnancy Test Device) routinely used in the laboratory.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
(1) Non-Clinical Tests
The tests were done for UniMark® hCG Pregnancy Test (K941090) and summarized in the Performance Characteristics of the UniMark® hCG Pregnancy Test Device. Please see the package insert of UniMark® hCG Pregnancy Test Device (Attachment D, page 20 - 22) and the following summarization.
PERFORMANCE CHARACTERISTICS
Sensitivity
UniMark® hCG pregnancy test device detects urinary hCG concentrations of 25 mIU/ml or greater (WHO 3td IS 75/537).
Accuracy
364 randomly selected urine specimen, 189 positive and 175 negative, were analyzed by the UniMark® hCG test in parallel with a commercially available quantitative visual hCG test. The result shows complete agreement.
Specificitv
During the specificity (cross-reactivity) study, the negative results were obtained from all of the UniMark® hCG pregnancy test device assayed with 200 mIU/ml hLH. 1000 mIU/ml hFSH and 1000 uIU/ml hTSH.
Interference Testing
The amount of the following substances added to the urine specimen will not interfere with UniMark® hCG pregnancy test.
Acetaminophen 20 mg/dl
Acetylsalicylic Acid 20 mg/dl
Ascorbic Acid 20 mg/dl
Atropine 20 mg/dl
Caffeine 20 mg/dl
Gentisic Acid 20 mg/dl
Glucose 2000 mg/dl
Hemoglobin 1 mg/dl
Protein 2000 mg/dl
PH 5 to 9
(2) Consumer Study
The UniMark® Home Pregnancy Test Device was evaluated in a consumer study of 100 home users selected on a random basis as they presented themselves at the offices or labs of the assigned organizers in central New Jersey and New York City. The home users represented a diverse ages, backgrounds, and educational levels.
Urine specimens from non-pregnant women were examined and mixed as an hCG-free specimen. The specimens were split into 4 fractions and spiked with hCG to the concentrations of 0, 20 (20% lower than 25 mIU/ml, the sensitivity level), 30 (20% higher than 25 mIU/ml) and 1000 mIU/ml. Each fraction was further split into dropping bottles. The bottles were labeled with codes. 4 pregnancy devices and one coded control set (0, 20, 30, 1000 mIU/ml) were placed into one bag as one study-kit.
The study was explained to the home users by the organizer or lab technician. If the home user agreed to participate, written and verbal instructions on how to perform the test were provided with one study-kit. The home user performed the test procedure for each of the four controls and read the results. At the conclusion of the test, each home user was asked to complete and sign a questionnaire to obtain feedback on the test. The home user marked the used devices with a control code and her name. The user test results were observed and verified by the organizer or lab assistant to verify correct interpretation of positive or negative. The form, the control set, and tested devices were put back into the plastic bag as a back-kit. All of the back-kits were sent back to Biotech Atlantic. The lab technician of Biotech Atlantic subsequently tested the set of coded controls in the back-kit from each home user with the professional (predicate) test (UniMark® hCG Pregnancy Test Device) routinely used in the laboratory.
There was 100% correlation between the UniMark® home user and the UniMark® professional test results, as shown in Table 2 below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: UniMark® hCG pregnancy test device detects urinary hCG concentrations of 25 mIU/ml or greater (WHO 3td IS 75/537).
Accuracy: The result shows complete agreement.
Specificity: During the specificity (cross-reactivity) study, the negative results were obtained from all of the UniMark® hCG pregnancy test device assayed with 200 mIU/ml hLH. 1000 mIU/ml hFSH and 1000 uIU/ml hTSH.
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.
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.
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) SUMMARY OF INFORMATION RESPECTIN 10. EFFECTIVENESS
A. Name and Address of Submitter
| Company Name and Address: | Biotech Atlantic, Inc.
6 Industrial Way West
Eatontown, NJ 07724 |
|---------------------------|------------------------------------------------------------------------|
| Telephone: | 732-389-4789 |
| Fax: | 732-389-3837 |
| Contact Person: | Francis Ling Deng |
| Device Name | |
| Proprietary Name: | UniMark® Home Pregnancy Test Device |
| Common Name: | hCG Pregnancy Test |
|---|---|
| Classification: | Human Chorionic Gonadotropin (hCG) Test System |
- C. Legally Marketed Devices
UniMark® hCG Pregnancy Test (device and strip), K941090
UniMark® Midstream Pregnancy Test Stick, K960174
D. Device description
B.
The UniMark® Home Pregnancy Test Device is a colored solid-phase Chromatographic Immunoassay (CIA) for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is a home use, rapid, visual, one step pregnancy screening test.
Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone synthesized by the placenta and released in blood and urine soon after the implantation of a fertilized ovum in the chorionic tissue. HCG is the principal signal and specific marker of the pregnancy. During the test, the specimen is sucked up through the conjugate pad. The hCG in the specimen is captured by the mouse anti-beta hCG antibodies conjugated to colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat anti-hCG antibodies at the test zone of the membrane to form an antibody-hCG-gold conjugate complex. An appearance of a purple band in the test zone is the positive result, which indicates the presence of an hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a
1
negative result, i.e. no detectable hCG in the specimen. The appearance of the purple band in the control window demonstrates proper performance and validity of the reactive reagent.
-
E. Intended Use
The UniMark® Home Pregnancy Test Device is intended for the qualitative measurement of human Chorionic Gonadotropin (hCG) in urine as a home use screening test for pregnancy. -
F. Comparison with Predicate Device
A summary comparison of the features of UniMark® Home Pregnancy Test Device, UniMark® hCG Pregnancy Test Device, UniMark® Midstream Pregnancy Test Stick are provided in Table 1 of section 9-A. -
G. Performance Data
- (1) Non-Clinical Tests
The tests were done for UniMark® hCG Pregnancy Test (K941090) and summarized in the Performance Characteristics of the UniMark® hCG Pregnancy Test Device. Please see the package insert of UniMark® hCG Pregnancy Test Device (Attachment D, page 20 - 22) and the following summarization.
PERFORMANCE CHARACTERISTICS
Sensitivity
UniMark® hCG pregnancy test device detects urinary hCG concentrations of 25 mIU/ml or greater (WHO 3td IS 75/537).
Accuracy
364 randomly selected urine specimen, 189 positive and 175 negative, were analyzed by the UniMark® hCG test in parallel with a commercially available quantitative visual hCG test. The result shows complete agreement.
Specificitv
During the specificity (cross-reactivity) study, the negative results were obtained from all of the UniMark® hCG pregnancy test device assayed with 200 mIU/ml hLH. 1000 mIU/ml hFSH and 1000 uIU/ml hTSH.
Interference Testing
The amount of the following substances added to the urine specimen will not interfere with UniMark® hCG pregnancy test.
| Acetaminophen | 20 | mg/dl |
|---|---|---|
| Acetylsalicylic Acid | 20 | mg/dl |
2
| Ascorbic Acid | 20 | mg/dl |
|---|---|---|
| Atropine | 20 | mg/dl |
| Caffeine | 20 | mg/dl |
| Gentisic Acid | 20 | mg/dl |
| Glucose | 2000 | mg/dl |
| Hemoglobin | 1 | mg/dl |
| Protein | 2000 | mg/dl |
| PH | 5 to 9 |
(2) Consumer Study
The UniMark® Home Pregnancy Test Device was evaluated in a consumer study of 100 home users selected on a random basis as they presented themselves at the offices or labs of the assigned organizers in central New Jersey and New York City. The home users represented a diverse ages, backgrounds, and educational levels.
Urine specimens from non-pregnant women were examined and mixed as an hCG-free specimen. The specimens were split into 4 fractions and spiked with hCG to the concentrations of 0, 20 (20% lower than 25 mIU/ml, the sensitivity level), 30 (20% higher than 25 mIU/ml) and 1000 mIU/ml. Each fraction was further split into dropping bottles. The bottles were labeled with codes. 4 pregnancy devices and one coded control set (0, 20, 30, 1000 mIU/ml) were placed into one bag as one study-kit.
The study was explained to the home users by the organizer or lab technician. If the home user agreed to participate, written and verbal instructions on how to perform the test were provided with one study-kit. The home user performed the test procedure for each of the four controls and read the results. At the conclusion of the test, each home user was asked to complete and sign a questionnaire to obtain feedback on the test. The home user marked the used devices with a control code and her name. The user test results were observed and verified by the organizer or lab assistant to verify correct interpretation of positive or negative. The form, the control set, and tested devices were put back into the plastic bag as a back-kit. All of the back-kits were sent back to Biotech Atlantic. The lab technician of Biotech Atlantic subsequently tested the set of coded controls in the back-kit from each home user with the professional (predicate) test (UniMark® hCG Pregnancy Test Device) routinely used in the laboratory.
There was 100% correlation between the UniMark® home user and the UniMark® professional test results, as shown in Table 2 below.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are abstract and appear to be connected, forming a single, unified shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
NOV 2 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Francis Ling Deng Chief Executive Officer Biotech Atlantic, Inc. Bay F. 6 Industrial Way West Eatontown, NJ 07724
Re: K032992
Trade/Device Name: UniMark® Home Pregnancy Test Device Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 23 2003 Received: September 25, 2003
Dear Mr. Deng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INDICATIONS FOR USE
UniMark® Home Pregnancy Test Device
UniMark® Home Pregnancy Test Device (provided as a test strip contained within a plastic test strip holding cassette) is for the rapid and qualitative determination of humane Chorionic Gonadotropin (hCG) in urine. It is intended for consumer use at home.
It is indicated for use in the early detection of pregnancy.
Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use '
Per 21 CRF 801.109
(Optional Format 1-2-96)
Carol C. Benen for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)K032992
- 19 -