(68 days)
SAS™ Pregnancy Strip
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No
The device description and performance studies describe a chemical assay based on antibody reactions and visual interpretation of color lines. There is no mention of AI, ML, image processing, or any computational analysis of the results.
No
The device is a diagnostic test for pregnancy, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "to aid in the diagnosis of pregnancy."
No
The device description clearly outlines a physical test strip with reagent pads and antibodies that react with urine, indicating a hardware component is central to its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of human Chorionic Gonadotropin in human urine to aid in the diagnosis of pregnancy." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information for a diagnosis.
- Device Description: The description details how the device works by detecting a substance (hCG) in a biological sample (urine) using antibodies and a chemical reaction, which is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes performance studies evaluating the device's sensitivity and specificity in detecting hCG in urine samples, which are standard evaluations for IVD devices.
N/A
Intended Use / Indications for Use
Affirm One-Step Professional 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 Professional use.
Product codes (comma separated list FDA assigned to the subject device)
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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 to the reagent pad where the hCG reacts with the conjugate, and then through the membrane containing bound capture antibodies. 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
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Professional 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
Description of the test set, sample size, data source, and annotation protocol: The sensitivity of the Affirm One-Step Professional Pregnancy Test was determined using 20 negative urine samples spiked with hCG at varying levels.
One hundred and four specimens were evaluated by the urine stream method and the dir method. The women participating in the study were solicited by a flyer appearing in clinics locally, and asked to participate at one of the following locations: Athena Medical Corporation, Planned Parenthood in either Southeast Portland or Beaverton, Oregon.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Specificity: Affirm One-Step Professional Pregnancy Test was evaluated for specificity against LH (300 mIU/ml), FSH (1000 mlU/ml), and TSH (1000 ulU/ml. Affirm did not cross-react with these substances at these levels, nor were samples spiked with 25 mIU/ml concentration of hCG inhibited by these substances.
Sensitivity: The sensitivity of the Affirm One-Step Professional Pregnancy Test was determined using 20 negative urine samples spiked with hCG at varying levels. Of the 20 samples that were tested at the 10 mIU/ml concentration, 5 of them generated a positive reading after about 15 minutes from the point of sauration. The 20 samples tested at the 25 mIU/ml concentration all generated a positive reading within 4 minutes. Therefore our claim is a 25 mIU/ml sensitivity with the Affirm One-Step Professional Pregnancy Test.
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. Substances tested include Acetaminophen, Acetylsalicylic Acid, Ascorbic Acid, Atropine, Caffeine, Gentisic Acid, Glucose, and Hemoglobin, with no interference observed at the tested concentrations.
Predicate Device Accuracy Correlation: One hundred and four specimens were evaluated by the urine stream method and the dir method. The women who participated in the urine stream method identified 53 true positives and 46 true negatives, with 1 false negative, generating a 99% user accuracy rate for the Affirm One-Step Professional Pregnancy Test. The laboratory comparison of the same collected samples using the SAS™ Pregnancy Strip identified 54 true positives and 46 true negatives, generating a 100% laboratory accuracy rate. There were four invalid results due to insufficient urine placed on the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: As low as 25 mIU/ml.
Specificity: No cross-reactivity with LH (300 mIU/ml), FSH (1000 mlU/ml), and TSH (1000 ulU/ml).
Accuracy Rate (User): 99% (53 true positives, 46 true negatives, 1 false negative out of 100 specimens for the subject device).
Accuracy Rate (Laboratory, using predicate): 100% (54 true positives, 46 true negatives out of 100 specimens for the predicate device).
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.
SAS™ Pregnancy Strip
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
K964574
Jan. 21, 1997
510 (k) SUMMARY
AFFIRM ONE STEP PROFESSIONAL PREGNANCY TEST
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510(k) Summary
Athena Medical Corporation
10180 SW Nimbus Ave. Suite J-5 Portland, OR 97223
Patricia Feetham
Phone: 503/968-8800 ext. 19
Fax: 503/639-3674 Proprietary Name: Product Name: Affirm One-Step Professional Pregnancy Test Classification Name: human Chorionic Gonadotropin test systems Affirm One-Step Professional 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 Professional use. Description of Device: 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 to the reagent pad where the hCG reacts with the conjugate, and then through the membrane containing bound capture antibodies. 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.
Predicate device for substantial equivalence comparison:
Date Prepared:
Submitted by:
Intended Use:
Contact:
SAS™ Pregnancy Strip
November 1, 1996
2
Substantial Equivalence:
Comparison Product: SAS™ Pregnancy Strip SA Scientific™ Scientific™
4919 Golden Quail Manufactured by: San Antonio TX 78240
Similarities to SAS™ Pregnancy Strip:
| Items to be compared | Affirm One-Step Professional
Pregnancy Test | SAST™ Pregnancy Strip |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • 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. |
| • Method | Mid-stream or dip. | Dip only. |
| • 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 hCG
antibody is on the test strip,
monoclonal anti-beta hCG
antibody is on the conjugate pad,
and polyclonal goat anti-mouse
IgG antibody is on the control line. | Polyclonal goat anti-alpha hCG
antibody is on the test strip,
monoclonal anti-beta hCG
antibody is on the conjugate pad,
and polyclonal goat anti-mouse
IgG 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 specimen
zone and control zone.
Negative = color line in control
zone only. |
| • Format: | Lateral Flow assay. | Lateral Flow assay. |
| • Sensitivity: | Detects level of hCG as low as
25 mIU/ml. | Detects level of hCG as low as
25 mIU/ml. |
| • Device design: | Slender, pen-like shape, removable
cap, absorbent tip partially
enclosed, two window result view. | Test strip utilizing an immersion
zone, a specimen zone and control
zone. |
| • 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 band appears in
specimen and control zones in the
presence of hCG.
A solid color band appears in the
control zone only in the absence of
hCG. |
| Items to be compared | Affirm One-Step Professional
pregnancy test | SAST™ Pregnancy Strip |
| • Device engineering: | Test device which contains an
exposed absorbent wick, a
conjugate pad, nitrocellulose
membrane containing bound
antibodies, and a wicking pad in
a disposable plastic container.
Result windows and two "tear
drop" openings exposing the
absorbent wick appear on the
same side of the device. Area
covering wick is a small cap.
Result and control windows
include a moisture resistant clear
barrier. | Test strip only, which contains an
exposed absorbent wick, a
conjugate pad, nitrocellulose
membrane containing bound
antibodies, and a wicking pad.
Test strips are stored in a
desiccated canister until ready for
use. |
| • Developing time: | Minimum of 4 minutes for
negative results to appear;
positive results as soon as 1 - 2
minutes (see Appendix A).
Maximum of 20 minutes for any
result. | Read results after 5 minutes. Do
not interpret results after 30
minutes. |
| • Absorbent wick: | Partially enclosed with 2 tear drop
openings in the plastic housing. | Wick is bottom 1/3 of test strip. |
| • Results windows: | Covered by a clear plastic shield
which acts as splash guard to
protect the results. | Colored bands are displayed in
the specimen and/or control zone
on the strip. |
| • Test window/Control window: | Test window shape is: "+".
control window shape is: "O". | Test zones are bands in the
middle to upper quadrant of the
test strip. |
| • Color of holder: | Ivory | No holder |
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The differences between the Affirm One-Step Professional Pregnancy Test and SASTM Pregnancy Strip are not significant and do not effect the safety and effectiveness of the device.
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Performance characteristics:
Specificity:
Affirm One-Step Professional Pregnancy Test was evaluated for specificity against LH (300 mIU/ml), FSH (1000 mlU/ml), and TSH (1000 ulU/ml. Affirm did not cross-react with these substances at these levels, nor were samples spiked with 25 mIU/ml concentration of hCG inhibited by these substances.
Sensitivity:
The sensitivity of the Affirm One-Step Professional Pregnancy Test was determined using 20 negative urine samples spiked with hCG at varying levels. The results are described in the table below.
| Concentration
| Spiked at: | Results: Positive | Results: Negative |
|---|---|---|
| 10 mIU/ml | 5 | 15 |
| 25 mIU/ml | 20 | 0 |
| 50 mIU/ml | 20 | 0 |
| 100 mIU/ml | 20 | 0 |
| 0 mIU/ml | 0 | 20 |
Sensitivity of Affirm One-Step Professional Pregnancy Test:
Of the 20 samples that were tested at the 10 mIU/ml concentration, 5 of them generated a positive reading after about 15 minutes from the point of sauration. The 20 samples tested at the 25 mIU/ml concentration all generated a positive reading within 4 minutes. Therefore our claim is a 25 mIU/ml sensitivity with the Affirm One-Step Professional Pregnancy Test. Even though the test is sensitive enough to read concentrations lower than 25 mIU/ml this does not occur regularly for us to claim a lower sensitivity for the test.
5
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 below:
| Substance: | Concentration: | Interference: |
|---|---|---|
| Acetaminophen | 20 mg/dl | NONE |
| Acetylsalicylic Acid | 20 mg/dl | NONE |
| Ascorbic Acid | 20 mg/dl | NONE |
| Atropine | 20 mg/dl | NONE |
| Caffeine | 20 mg/dl | NONE |
| Gentisic Acid | 20 mg/dl | NONE |
| Glucose | 2 g/dl | NONE |
| Hemoglobin | 200 mg/dl | NONE |
Interference of the Affirm One-Step Professional Pregnancy Test
Predicate Device Accuracy Correlation:
One hundred and four specimens were evaluated by the urine stream method and the dir method. The women participating in the study were solicited by a flyer appearing in clinics locally, and asked to participate at one of the following locations: Athena Medical Corporation, Planned Parenthood in either Southeast Portland or Beaverton, Oregon. Women who participated in the urine stream method answered a questionnaire about the product. The women participants identified 53 true positives and 46 true negatives, with 1 false negative, generating a 99% user accuracy rate for the Affirm One-Step Professional Pregnancy Test. The laboratory comparison of the same collected samples using the SAS™ Pregnancy Strip identified 54 true positives and 46 true negatives, generating a 100% laboratory accuracy rate. There were four invalid results due to insufficient urine placed on the device.