(61 days)
OneStep Be Sure® Plus Midstream Pregnancy Home Test
SASTM Pregnancy Strip
No
The device description and performance studies indicate a traditional immunoassay based on antibody reactions and visual interpretation of color lines. There is no mention of AI/ML, image processing, or complex data analysis.
No
The device is a diagnostic test for pregnancy, not a device intended to treat or alleviate a medical condition.
Yes
The device is described as a rapid one-step visual test for the qualitative detection of human chorionic gonadotropin in human urine to aid in the diagnosis of pregnancy. The "aid in the diagnosis of pregnancy" explicitly states its diagnostic purpose.
No
The device description clearly outlines a physical test strip with reagent pads and capillary action, indicating a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin in human urine to aid in the diagnosis of pregnancy." This involves testing a biological sample (urine) outside of the body to provide information for a medical diagnosis (pregnancy).
- Device Description: The description details how the device works by detecting a specific analyte (hCG) in a biological sample (urine) using antibodies. This is a characteristic of IVD tests.
- Performance Studies: The document includes performance studies evaluating the device's sensitivity, specificity, and accuracy using urine samples. This type of testing is standard for IVD devices to demonstrate their reliability.
The fact that it's intended for "over-the-counter home use" doesn't change its classification as an IVD. Many IVD devices are designed for use by lay users in a home setting.
N/A
Intended Use / Indications for Use
Affirm One-Step home pregnancy test is a rapid one-step visual test for the qualitative detection of human chorionic gonadotropin in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Affirm detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by one color line in the test window and one color line in the control window. The absence of hCG produces only one color line in the control window.
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
over-the-counter 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
Specificity: Affirm One-Step home pregnancy test was evaluated for specificity against LH, FSH and TSH. At concentrations of 300mIUml LH, and 1000mIU/ml FSH and TSH. Affirm did not cross-react with these substances at these levels. Only when Affirm was compared to these three substances and a 25mlU/ml concentration of hCG simultaneously did the tests respond and show a positive reading for the presence of hCG.
Sensitivity and Accuracy: The sensitivity and accuracy of the Affirm One-Step home pregnancy test was determined using 20 negative urine samples spiked with hCG at varying levels.
Interfering Substances: The following potentially interfering substances were added to hCG negative and 25 mIU/ml hCG spiked urine samples. Interfering test samples were compared directly to the control result.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Specificity: Affirm One-Step home pregnancy test was evaluated for specificity against LH, FSH and TSH. At concentrations of 300mIUml LH, and 1000mIU/ml FSH and TSH. Affirm did not cross-react with these substances at these levels. Only when Affirm was compared to these three substances and a 25mlU/ml concentration of hCG simultaneously did the tests respond and show a positive reading for the presence of hCG.
Sensitivity and Accuracy: The sensitivity and accuracy of the Affirm One-Step home pregnancy test was determined using 20 negative urine samples spiked with hCG at varying levels.
Interfering Substances: The following potentially interfering substances were added to hCG negative and 25 mIU/ml hCG spiked urine samples. Interfering test samples were compared directly to the control result.
Predicate Device Result Correlation: One hundred specimens were evaluated by the urine stream method and the dip method. The women participating in the study were solicited by a flyer appearing in clinics around town. and asked to participate at one of the following locations: Athena Medical Corporation, Planned Parenthood in either Southeast Portland or Beaverton. Women who participated in the urine stream method answered a questionnaire about the product. Both the Affirm One-Step home pregnancy test and the SASTM Pregnancy Strip identified 54 true positives and 46 true negatives generating a 100% sensitivity for the Affirm One-Step home pregnancy test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25mlU/ml. Out of the 20 samples that were tested at the 10mIUml concentration, 5 of them did generate a positive reading after about 15 minutes from the point of saturation. The 20 samples tested at the 25mlU/ml concentration all generated a positive reading well within the 20 minutes.
Specificity: Affirm did not cross-react with LH, FSH, and TSH at concentrations of 300mIUml LH, and 1000mIU/ml FSH and TSH.
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.
OneStep Be Sure® Plus Midstream Pregnancy Home Test
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.
SASTM Pregnancy Strip
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
Athena Medical Corporation 10180 SW Nimbus Ave. Suite J-5 Portland, OR 97223
SEP 23 1996
Krista Lopardo Phone: 503/968-8800 ext. 19 Fax: 503/639-3674
Proprietary Name: Affirm One-Step home pregnancy test
Classification Name: Human chorionic gonadtropin test systems
Affirm One-Step home pregnancy test is a rapid one-step visual test for the qualitative detection of human chorionic gonadotropin in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.
Affirm detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by one color line in the test window and one color line in the control window. The absence of hCG produces only one color line in the control window.
OneStep Be Sure® Plus Midstream Pregnancy Home Test
SASTM Pregnancy Strip
July 19, 1996
Submitted by:
Contact:
Product Name:
Intended Use:
Description of Device:
Predicate device for substantial equivalence comparison:
Predicate device used as reference test for clinical data:
Date Prepared:
1
Performance characteristics:
Specificity:
Affirm One-Step home pregnancy test was evaluated for specificity against LH, FSH and TSH. At concentrations of 300mIUml LH, and 1000mIU/ml FSH and TSH. Affirm did not cross-react with these substances at these levels. Only when Affirm was compared to these three substances and a 25mlU/ml concentration of hCG simultaneously did the tests respond and show a positive reading for the presence of hCG.
Sensitivity and Accuracy:
The sensitivity and accuracy of the Affirm One-Step home pregnancy test was determined using 20 negative urine samples spiked with hCG at varying levels. The following results are described in the table on the following page.
| Concentration
| Spiked at: | Results: Positive | Results: Negative |
|---|---|---|
| 10mIU/ml | 5 | 15 |
| 25mIU/ml | 20 | 0 |
| 50mIU/ml | 20 | 0 |
| 100mIU/ml | 20 | 0 |
| 0mIU/ml | 0 | 20 |
Sensitivity of Affirm One-Step home pregnancy test
Out of the 20 samples that were tested at the 10mIUml concentration, 5 of them did generate a positive reading after about 15 minutes from the point of saturation. The 20 samples tested at the 25mlU/ml concentration all generated a positive reading well within the 20 minutes, therefore our claim is a 25mlUml sensitivity with the Affirm One-Step home pregnancy test. Even though the test is sensitive enough to read concentrations lower than 25mIU/ml this does not occur regularly for us to claim a lower sensitivity for the test.
2
Interfering Substances:
The following potentially interfering substances were added to hCG negative and 25 mIU/ml hCG spiked urine samples. Interfering test samples were compared directly to the control result. The following results are described in the table:
| Substance: | Concentration: | Interference: |
|---|---|---|
| Acetaminophen | 20 mg/dI | NONE |
| Acetylsalicylic Acid | 20 mg/dI | NONE |
| Ascorbic Acid | 20 mg/dI | NONE |
| Atropine | 20 mg/dI | NONE |
| Caffeine | 20 mg/dI | NONE |
| Gentisic Acid | 20 mg/dI | NONE |
| Glucose | 2 mg/dI | NONE |
| Hemoglobin | 200 mg/dI | NONE |
Interference of the Affirm One-Step home pregnancy test
Predicate Device Result Correlation:
One hundred specimens were evaluated by the urine stream method and the dip method. The women participating in the study were solicited by a flyer appearing in clinics around town. and asked to participate at one of the following locations: Athena Medical Corporation, Planned Parenthood in either Southeast Portland or Beaverton. Women who participated in the urine stream method answered a questionnaire about the product. Both the Affirm One-Step home pregnancy test and the SAS™ Pregnancy Strip identified 54 true positives and 46 true negatives generating a 100% sensitivity for the Affirm One-Step home pregnancy test.
3
Substantial Equivalence:
| Comparison Product: | Be Sure® Plus |
|---|---|
| Manufactured by: | Syntron Bioresearch Inc. |
| Carlsbad, CA 92008 |
Similarities to Be Sure® Plus:
| Items to be compared | Affirm One-Step home
pregnancy test | Be Sure® Plus |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| · Detection method: | hCG in urine specimens reacts
with the colored-conjugate on the
pad producing a solid color (red)
line in the test region. Mouse
conjugate binds to goat anti-
mouse antibody in the control
region on the strip. | hCG in urine specimens reacts
with the colored-conjugate on the
pad producing a solid color (red)
line in the test region. Mouse
conjugate binds to goat anti-
mouse antibody in the control
region on the strip. |
| · Usage: | Anytime of the day. | Anytime of the day. |
| · Pregnancy determination: | As early as the first day of a
women's missed period. | As early as the first day of a
women's missed period. |
| · Antibodies: | Polyclonal goat anti-alpha
antibody hCG is on the test strip,
monoclonal anti-beta antibody
hCG is on the conjugate pad, and
polyclonal goat anti-mouse
antibody is on the control line. | Polyclonal goat anti-alpha
antibody hCG is on the test strip,
monoclonal anti-beta antibody
hCG is on the conjugate pad, and
polyclonal goat anti-mouse
antibody is on the control line. |
| · Results: | Positive = color line in test
window and control window.
Negative = color line in control
window only. | Positive = color line in test
window and control window.
Negative = color line in control
window only. |
| · Format: | Lateral Flow assay | Lateral Flow assay |
| · Sensitivity: | Detects level of hCG as low as
25mIU/ml. | Detects level of hCG as low as
25mIU/ml. |
| · Device design: | Slender, pen-like shape,
removable cap, absorbent tip
partially enclosed, two window
result view. | Slender, pen-like shape,
removable cap, absorbent tip
partially enclosed, two window
result view. |
| · Visual detection: | A solid color line appears in
control and test window in the
presence of hCG.
A solid color line appears in the
control window only in the
absence of hCG. | A solid color line appears in
control and test window in the
presence of hCG.
A solid color line appears in the
control window only in the
absence of hCG. |
| Items to be compared | Affirm One-Step home
pregnancy test | Be Sure® Plus |
| • Device engineering: | Both the result windows and the
"tear drops" exposing the
absorbent wick appear on the
same side of the device. Area
covering wick is smaller
producing a smaller cap. Result
window includes a moisture
resistant clear barrier. | Both the result windows and the
2 square windows exposing the
absorbent wick are on opposite
sides of the device. Area covering
the absorbent wick is larger
producing a larger cap. |
| • Developing time: | Less than 4 minutes for the
results to appear. | Less than 5 minutes for the
results to appear. |
| • Absorbent wick: | Partially enclosed except for 2
"tear drops" carved out of the
plastic housing. | Partially enclosed except for 2
squares cut out of the plastic
housing. |
| • Results windows: | Covered by a clear plastic shield
which acts as splash guard to
protect the results. | Fully exposed result window
with no plastic covering. |
| • Test window/Control window: | Test window shape is: "+".
control window shape is: "o". | Test window is a rectangle while
the control window is a square. |
| • Color of holder: | Ivory | Blue/White |
4
Differences between Affirm and Be Sure® Plus:
The differences between the Affirm One-Step home pregnancy test and Be Sure® Plus are insignificant and do not effect the safety and effectiveness of the device in any significant way.