(15 days)
Not Found
No
The device description details a chromatographic immunoassay based on antibody binding and visual interpretation of color bands. There is no mention of AI, ML, image processing, or any computational analysis of the results. The performance studies are based on traditional metrics like sensitivity and specificity, not metrics typically associated with AI/ML performance (e.g., AUC, MRMC).
No
The device is a diagnostic tool used to detect pregnancy, not to treat any condition or restore health.
Yes
The device rapidly and qualitatively determines human chorionic gonadotropin (hCG) in serum and urine for the early detection and diagnosis of pregnancy, which is a diagnostic purpose.
No
The device description clearly outlines a physical test strip and a plastic test strip holding device, which are hardware components. The mechanism of action is a chromatographic immunoassay, a chemical process, not a software-based analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine." This involves testing a biological sample (serum and urine) outside of the body to gain information about a physiological state (pregnancy).
- Device Description: The description details a "chromatographic immunoassay (CIA)" that detects hCG in "serum and urine specimens." This is a common method used in IVD devices.
- Professional and Laboratory Use: The intended user is specified as "professional and laboratory use only," which is typical for many IVD devices that require trained personnel to perform the test and interpret the results.
The core function of the device is to analyze a biological sample in vitro (outside the living organism) to diagnose a condition (pregnancy), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.
It is indicated for use in the early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
UniMark® hCG Combo Pregnancy Test is a chromatographic immunoassay (CIA) for qualitative detection of elevated levels of hCG in serum and urine specimens for the early pregnancy diagnosis. 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 coated on colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat antihCG 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 presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negtive 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
It is intended for professional and laboratory use only.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the UniMark® Combo hCG Pregnancy Test (Strip and Device) are provided in the package insert, and included sensitivity, accuracy (correlation), specificity, and interference testing with both serum and urine specimens. Sensitivity and accuracy studies were performed in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test, currently in commercial distribution by Applied Biotech.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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) SUMMARY OF INFORMATION RESPECTING SAFETY AND 11. 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 Lee |
B. Device Names
| Proprietary Name: | UniMark® hCG Combo Pregnancy Test |
|---|---|
| Common Name: | hCG Pregnancy Test |
| Classification Name: | Human Chorionic Gonadotropin (hCG) Test System |
C. Legally Marketed Device
UniMark® hCG Pregnancy Test, K941090
D. Device Description
UniMark® hCG Combo Pregnancy Test is a chromatographic immunoassay (CIA) for qualitative detection of elevated levels of hCG in serum and urine specimens for the early pregnancy diagnosis. 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 coated on colloidal gold particles. The mixture moves up the membrane by capillary action and is captured by the immobilized goat antihCG 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 presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negtive 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.
1
E. Intended Use
UniMark® hCG Combo Pregnancy Test (Strip and Device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.
F. Comparison with Predicate Device
The UniMark® hCG Combo Pregnancy Test (Strip and Device) is the same as the UniMark® hCG Pregnancy Test (Strip and Device) with the following exceptions:
- UniMark® hCG Combo Pregnancy Test is intended for use with both l serum and urine specimens; the UniMark® hCG Pregnancy Test is intended for use with urine specimens only
- UniMark® hCG Combo Pregnancy Test contains an additional reagent, ﺳ normal mouse IgG, in the sample pad to block the nonspecific binding sites of the proteins or antibodies in a serum sample. This minimizes the potential for false positive readings when serum samples are tested.
G. Performance Data
The performance characteristics of the UniMark® Combo hCG Pregnancy Test (Strip and Device) are provided in the package insert, and included sensitivity, accuracy (correlation), specificity, and interference testing with both serum and urine specimens. Sensitivity and accuracy studies were performed in comparison with another combo hCG pregnancy test, the SureStep hCG Combo Pregnancy Test, currently in commercial distribution by Applied Biotech.
H. Conclusions Drawn from the Studies
The conclusions drawn from the performance studies demonstrate that the UniMark® Combo hCG Pregnancy Test is as safe, effective, and performs as well as the legally marketed device to which equivalence is claimed, the UniMark® hCG Pregnancy Test when tested with urine specimens. Further, the sensitivity and accuracy of the UniMark® Combo hCG Pregnancy Test demonstrate that the test is as safe, effective, and performs as well as a legally marketed combo device when tested with both serum and urine specimens.
//
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image. The logo is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 0 2001
Mr. Francis Lee Chief Executive Officer Biotech Atlantic, Inc. Meridan Center III Bay F. 6 Industrial Way West Eatontown, NJ 07724
Re: K013194
Trade/Device Name: UniMark ® hCG Combo Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: September 24, 2001 Received: September 25, 2001
Dear Mr. Lee:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Autman
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
STATEMENT OF INDICATIONS FOR USE
UniMark® hCG Combo Pregnancy Test
UniMark® hCG Combo Pregnancy Test (provided either as an individual test strip or as a test strip contained within a plastic test strip holding device) is for the rapid and qualitative determination of human chorionic gonadotropin (hCG) in serum and urine. It is intended for professional and laboratory use only.
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_1
OR
Over-the-Counter-Use
Per 21 CFR 801.109
(Optional Format 1-2-96)
Sean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_ 1 0 13 1914
2