(76 days)
Not Found
No
The device description details a chemical immunoassay with visual interpretation, and there is no mention of AI or ML in the document.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a diagnostic test for pregnancy, which is a physiological state, not a disease or condition to be treated.
Yes
The UniMark™ Midstream Pregnancy Test Stick is described as intended for the "qualitative measurement of human chorionic gonadotropin (hCG) in urine as a home use screening test for pregnancy," which is a diagnostic purpose. It "detects elevated levels of hCG in urine for the early pregnancy diagnosis."
No
The device description clearly outlines a physical immunoassay test stick with a sample pad, membrane, and reactive reagents, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "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 (presence of hCG indicating pregnancy).
- Device Description: The description details a "colored solid-phase immunoassay for qualitative detection of elevated levels of hCG in urine." This is a common method used in IVD tests. It describes the components and how they interact with the urine sample to produce a result.
- Performance Studies: The document describes both non-clinical and clinical studies evaluating the device's performance (sensitivity, specificity, accuracy) using urine samples. This is standard practice for demonstrating the reliability of an IVD.
- Key Metrics: The document provides key metrics like sensitivity, accuracy, and specificity, which are crucial for evaluating the performance of an IVD.
The fact that it is a "home use" test does not preclude it from being an IVD. Many IVDs are designed for use by lay users in a home setting.
N/A
Intended Use / Indications for Use
The UniMark™ Midstream Pregnancy Test Stick is intended for the qualitative measurement of human chorionic gonadotropin (hCG) in urine as a home use screening test for pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The UniMark™ Midstream Pregnancy Test Stick is a home use, rapid, visual, one step screening test for pregnancy. UniMark™ is a colored solid-phase immunoassay for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is based on a two-site sandwich immunometric assay which utilizes a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG with a high degree of sensitivity. UniMark™ contains a strip with a sample pad and a membrane area. The former contains mouse anti-hCG monoclonal antibody conjugated with colloid gold. The latter is coated with goat anti-mouse IgG at the control zone and goat anti-hCG antibody at the test zone. During the test, the urine is sucked up through sample pad by capillary action, and hCG in the urine sample binds to the gold conjugate, moving chromatographically toward the membrane. The immobilized goat anti-hCG antibody at the test zone catches the resulting complexes, forming an antibody-hCG-gold conjugate complex. The appearance of a purple band in the test window resulted from the complex shows a positive result, which indicates presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the urine sample. The appearing of a 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
home use
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™ was evaluated in a consumer study of 146 home users selected on a random basis as they presented themselves at a women's center in southern New Jersey. The home users represented a diversity of age, background and education. The study was explained to the home users by either the center's nurse or lab assistant. If the home user agreed to participate, written and verbal instructions on how to perform the test were provided. In addition to performing the midstream test procedure, the home users were asked to collect a sample of the same urine specimen. At the conclusion of the test, each home user was asked to complete a questionnaire to obtain feedback on the test. The user test results were observed and verified by the lab assistant (to verify correct interpretation of positive or negative).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
Sensitivity: The device was tested with hCG concentrations from 0 mIU/ml to 100 mIU/ml. At 25 mIU/ml, all three lots showed 100% positive results.
Specificity:
hLH Study: The device showed no interference with hLH at concentrations up to 200 mIU/ml, and consistently detected hCG when hLH was present.
hFSH Study: The device showed no interference with hFSH at 1000 mIU/ml, and consistently detected hCG when hFSH was present.
hTSH Study: The device showed no interference with hTSH at 1000 uIU/ml, and consistently detected hCG when hTSH was present.
Clinical Tests:
Study Type: Consumer study
Sample Size: 146 home users
Key Results: There was 100% correlation between the UniMark™ home user and CIDA professional test results.
Correlation table:
UniMark™ Positive: 119, UniMark™ Negative: 27
CIDA Positive: 119, CIDA Negative: 27
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25mIU/ml or greater
Accuracy: >99%
Specificity: No interferences
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
K96 0174
1991 - 1992 - 1992 APR - 1 1996
- 510(k) Summary of Information Respecting Safety and Effectiveness 8.
- Legally Marketed Device A.
Biotech Atlantic claims substantial equivalence to the UniStep™ HCG Pregnancy Test Device (K941090) currently in commercial distribution (outside the U.S.) by Biotech Atlantic. Inc.
- B. Device Description
The UniMark™ Midstream Pregnancy Test Stick is a home use, rapid, visual, one step screening test for pregnancy.
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. The rapidly rising levels of hCG provide a stimulus to the corpus luteum (luteotrophic effect). Instead of involution in a non-pregnant menstrual cycle, the corpus luteum continues to grow and secretes increasing quantities of hormone progesterone which is needed to maintain pregnancy. Thus, hCG is the principal signal and specific marker of the pregnancy.
A number of variations were used for the next 30 years. They have been rapidly superseded in the 1960s because of their cost and inconvenience since immunoassays were introduced. Like other members of glycoprotein hormones, such as Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH), hCG is composed of two subunits: an alpha-subunit, which is virtually identical in all four; and a beta-subunit, which is characteristic of the individual hormone, therefore determines the specificity of the action. Use of monoclonal antibodies to the beta-subunit of hCG is an important which provides the feasibility to manufacture new generations of immunoassays with consistent specificity and high sensitivity to detect hCG. Pregnancy test now reaches a level which is generally considered unlikely to be surpassed either by better test or alternative technology.
UniMark™ is a colored solid-phase immunoassay for qualitative detection of elevated levels of hCG in urine for the early pregnancy diagnosis. It is based on a two-site sandwich immunometric assay which utilizes a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG with a high degree of sensitivity. UniMark™ contains a strip with a sample pad and a membrane area. The former contains mouse anti-hCG monoclonal antibody conjugated with colloid gold. The latter is coated with goat anti-mouse IgG at the control zone and goat anti-hCG antibody at the test zone. During the test, the urine is sucked up through sample pad by capillary action, and hCG in the urine sample binds to the gold conjugate, moving chromatographically toward the membrane. The immobilized goat anti-hCG antibody at the test zone catches the resulting complexes, forming an antibody-hCG-gold conjugate complex. The appearance of a purple band in the test window resulted from the complex shows a
1
positive result, which indicates presence of hCG and suggests a pregnancy. Absence of this band, on the other hand, displays a negative result, i.e. no detectable hCG in the urine sample. The appearing of a purple band in the control window demonstrates proper performance and validity of the reactive reagent.
-
C. Intended Use
The UniMark™ Midstream Pregnancy Test Stick is intended for the qualitative measurement of human chorionic gonadotropin (hCG) in urine as a home use screening test for pregnancy. -
D. Comparison with the Predicate Device
A summary comparison of the features of the UniMark™ and UniStep™ pregnancy tests is provided in Table 1 below.
2
8
Table 1.
Feature Comparison of the UniMark™ and UniStep™ Pregnancy Tests
| UniMark™ | UniStep™ | |
|---|---|---|
| Intended Use | Qualitative measurement | |
| of hCG | ||
| Home use | Qualitative measurement | |
| of hCG | ||
| Professional use | ||
| Reagents/Materials | Goat anti-hCG | |
| Mouse anti-hCG | ||
| Monoclonal conjugate | ||
| Plastic device with splash | ||
| guard and absorbent tip | Goat anti-hCG | |
| Mouse anti-hCG | ||
| Monoclonal conjugate | ||
| Plastic device | ||
| Assay Method | Colored solid-phase | |
| immunoassay | ||
| Midstream | Colored solid-phase | |
| immunoassay | ||
| Drop application | ||
| Specimen | Urine | Urine |
| Time of Collection | Any time of day | First a.m. preferred |
| Storage | 2° to 30° C | 2° to 30° C |
| Reaction Time | 5 minutes | 5 minutes |
| Positive Result | Purple band in Test | |
| Window | Purple band in Test | |
| Window | ||
| Standardization | WHO 3rd IS 75/537 | WHO 3rd IS 75/537 |
| Sensitivity | 25mIU/ml or greater | 25mIU/ml or greater |
| Accuracy | >99% | >99% |
| Specificity | No interferences | No interferences |
3
- E. Performance Data
Non-Clinical Tests
Sensitivity
| UniMark™
| Lot | HCG Concentration (mIU/ml), WHO 3rd IS 75/537) | ||||
|---|---|---|---|---|---|
| 0 | 20 | 25 | 50 | 100 | |
| 1 | -(100%) | -(95%) | |||
| ---+(5%) | +(100%) | ++(100%) | +++(100%) | ||
| 2 | -(100%) | -(95%) | |||
| ---+(5%) | +(100%) | ++(100%) | +++(100%) | ||
| 3 | -(100%) | -(95%) | |||
| ---+(5%) | +(100%) | ++(100%) | +++(100%) |
し
Specificity
hLH Study
| UniMark™
| Lot | hLH (mIU/ml) | hLH + hCG (MIU/ml) | |||||
|---|---|---|---|---|---|---|---|
| 0 | 10 | 100 | 200 | 10+25 | 100+25 | 200+25 | |
| 1 | - | - | - | - | + | + | + |
| 2 | - | - | - | - | + | + | + |
| 3 | - | - | - | - | + | + | + |
hFSH Study
| UniMark™
| Lot | hFSH (mIU/ml) | hFSH + hCG (mIU/ml) | |
|---|---|---|---|
| 0 | 1000 | 1000 + 25 | |
| 1 | - | - | + |
| 2 | - | - | + |
| 3 | - | - | + |
4
| UniMark™
| Lot | hTSH (uIU/ml) | hTSH + hCG (uIU+ mIU/ml) | |
|---|---|---|---|
| 0 | 1000 | 1000 + 25 | |
| 1 | - | - | + |
| 2 | - | - | + |
| 3 | - | - | + |
Clinical Tests
The UniMark™ was evaluated in a consumer study of 146 home users selected on a random basis as they presented themselves at a women's center in southern New Jersey. The home users represented a diversity of age, background and education.
The study was explained to the home users by either the center's nurse or lab assistant. If the home user agreed to participate, written and verbal instructions on how to perform the test were provided. In addition to performing the midstream test procedure, the home users were asked to collect a sample of the same urine specimen. At the conclusion of the test, each home user was asked to complete a questionnaire to obtain feedback on the test. The user test results were observed and verified by the lab assistant (to verify correct interpretation of positive or negative).
There was 100% correlation between the UniMark™ home user and CIDA professional test results, as shown in Table 2 below.
| | Table 2.
CIDA | |
|----------|------------------|----------|
| | Positive | Negative |
| UniMark™ | 119 | 27 |
| | 0 | 0 |
146✓