(15 days)
Hybritech ICON pregnancy test, FactPLUS Cup and Dropper Pregnancy Test
No
The device description details a standard immunoassay based on chemical reactions and visual interpretation, with no mention of computational analysis or learning algorithms.
No.
The device is a diagnostic test for pregnancy, not a therapeutic device designed to treat or alleviate a medical condition.
Yes
The device is designed for the "qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy," which is a diagnostic purpose. It determines the presence or absence of a specific biological condition (pregnancy) by analyzing a biological sample.
No
The device description clearly outlines a physical device made of molded plastic containing an internal test strip and utilizing an immunoassay based on chemical reactions and physical migration of urine. This is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is "a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to diagnose a condition (pregnancy).
- Over-the-counter in vitro test: The document directly labels the device as an "over-the counter in vitro test."
- Device Description: The description details the internal components and the biological principle (immunoassay) used to detect hCG in the urine sample. This further confirms its function as a diagnostic test performed on a biological specimen.
- Performance Studies: The document describes studies conducted to evaluate the device's accuracy, sensitivity, and specificity in detecting hCG in urine samples. These are standard performance metrics for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K962521; FactPLUS® One Step Pregnancy Test) is common in regulatory submissions for IVD devices, indicating a comparison to a previously cleared device of the same type.
All of these points clearly indicate that the ABBOTT Advisor One-Step Pregnancy Test is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABBOTT Advisor One-Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
The ABBOTT Advisor One-Step Pregnancy Test is an over-the counter in vitro test which can be used by the consumer to detect pregnancy as early as the first day of her missed period, using a direct urine stream sampling method. Some positive results appear as soon as three minutes, however, all results are confirmed when the Test Timer turns pink/red. The Test Timer will turn pink/red approximately 5 minutes after the urine has been added to the test device.
Product codes
Not Found
Device Description
The ABBOTT Advisor One-Step Pregnancy Test is an elongated device composed of two pieces of molded plastic which contain the internal test strip. The three openings on the device are the Urine Well, the Result Window and the Test Timer. The Result Window and the Test Timer are protected with a clear seal to prevent potential contamination caused by splashing urine.
The ABBOTT self-performing immunoassay for hCG in urine is based on the principle of a two site immunometric assay. Urine is added to the Urine Well, where it migrates through the Absorbent Pad to the Conjugate Pad portion of the test strip. As the urine moves through the Coniugate Pad, it mobilizes the mouse monoclonal anti-alpha hCG antibody coated colloidal particles. Any hCG present in the urine sample combines with the anti-alpha hCG antibody on the colloidal particle.
The urine, now containing an hCG-antibody-colloid complex and unbound colloid, continues to move up the test strip to the Result Window which contains immobilized polyclonal anti-BhCG on a vertical (Patient) bar and anti-mouse/anti-βhCG on a horizontal (Control) bar. The color generated is proportional to the concentration of hCG in the urine sample. Anti-hCG (mouse monoclonal) coated colloidal particles bind to the anti-mouse antibody immobilized on the Control Bar which indicates the assay is performing properly. A positive sign (+) indicates the presence of hCG. Low hCG concentration samples may display a "T" result, which is also interpreted as positive. The absence of detectable hCG will result in a negative sign (-). The assay is complete when the "Test Timer" indicator changes to pink or red, approximately three minutes after the start of the assay.
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 / over-the-counter
Self-performing immunoassay
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
Accuracy testing:
- Study Type: Laboratory testing
- Sample Size: 50 hCG-positive and 50 hCG-negative female clinical urine specimens
- Data Source: Advanced Care Products, using the Abbott device (FactPLUS One Step Pregnancy Test)
- Results: The device correctly identified 50/50 hCG-positive and 50/50 hCG-negative specimens. Tests were read immediately after the Test Timer turned pink/red, approximately 5 minutes after the start of the test.
- Confirmation: hCG-positive samples were confirmed with the Hybritech ICON pregnancy test. hCG-negative specimens were confirmed with the FactPLUS Cup and Dropper Pregnancy Test. At three minutes, agreement was 100% with the ICON and FactPLUS devices.
Consumer testing:
- Study Type: Clinical study
- Sample Size: 149 female volunteers
- Data Source: Volunteers recruited from a central New Jersey location
- Annotation Protocol: Volunteers were between the ages of 18 to 45, from various income, educational and employment backgrounds, and performed the test according to provided instructions.
- Results: Correct results were obtained by 146 of 149 subjects for an overall accuracy of 98%. 92% reported instructions were "very easy to understand", and 100% indicated instructions were "somewhat" or "very easy to understand".
Key Metrics
Laboratory testing: Accuracy of 100%, sensitivity of 100%, specificity of 100%.
Consumer clinical testing: Overall accuracy rate of 98%.
Predicate Device(s)
FactPLUS® One Step Pregnancy Test (K962521)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 2 4 1997
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The characters are K970082. The characters are written in black ink on a white background. The numbers are slightly rounded.
[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
ABBOTT Advisor® One-Step Pregnancy Test
1
[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Trade Name | ABBOTT Advisor One-Step Pregnancy Test |
|---|---|
| Common Name | Consumer Use Home Pregnancy Test |
| Classification Name | Human Chorionic Gonadotropin (hCG) |
| Test System | |
| Device Classification | Class II |
| Predicate Device Name | FactPLUS® One Step Pregnancy Test |
| (K962521) |
The following information as presented in the 510(k) Notification for the ABBOTT Advisor One-Step Pregnancy Test constitutes data supporting a substantially equivalent determination.
Intended Use
The ABBOTT Advisor One-Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Indications
The ABBOTT Advisor One-Step Pregnancy Test is an over-the counter in vitro test which can be used by the consumer to detect pregnancy as early as the first day of her missed period, using a direct urine stream sampling method. Some positive results appear as soon as three minutes, however, all results are confirmed when the Test Timer turns pink/red. The Test Timer will turn pink/red approximately 5 minutes after the urine has been added to the test device.
Device Description
The ABBOTT Advisor One-Step Pregnancy Test is an elongated device composed of two pieces of molded plastic which contain the internal test strip. The three openings on the device are the Urine Well, the Result Window and the Test Timer. The Result Window and the Test Timer are protected with a clear seal to prevent potential contamination caused by splashing urine.
2
The ABBOTT self-performing immunoassay for hCG in urine is based on the principle of a two site immunometric assay. Urine is added to the Urine Well, where it migrates through the Absorbent Pad to the Conjugate Pad portion of the test strip. As the urine moves through the Coniugate Pad, it mobilizes the mouse monoclonal anti-alpha hCG antibody coated colloidal particles. Any hCG present in the urine sample combines with the anti-alpha hCG antibody on the colloidal particle.
The urine, now containing an hCG-antibody-colloid complex and unbound colloid, continues to move up the test strip to the Result Window which contains immobilized polyclonal anti-BhCG on a vertical (Patient) bar and anti-mouse/anti-βhCG on a horizontal (Control) bar. The color generated is proportional to the concentration of hCG in the urine sample. Anti-hCG (mouse monoclonal) coated colloidal particles bind to the anti-mouse antibody immobilized on the Control Bar which indicates the assay is performing properly. A positive sign (+) indicates the presence of hCG. Low hCG concentration samples may display a "T" result, which is also interpreted as positive. The absence of detectable hCG will result in a negative sign (-). The assay is complete when the "Test Timer" indicator changes to pink or red, approximately three minutes after the start of the assay.
Statement of Substantial Equivalence
The ABBOTT Advisor One-Step Pregnancy Test is substantially equivalent to. and is the same device as the currently marketed FactPLUS® One Step Pregnancy Test (K962521) which is manufactured by Abbott Laboratories and distributed for over-the-counter sale by Direct Access Diagnostics, Bridgewater, New Jersey.
The intended use, technology, methodology, test chemistry, test analyte, component materials, sensitivity, specificity, and accuracy are the same for both the Abbott and the Direct Access Diagnostics devices. The devices can be used the first day of a missed period or menses, and at any time of the day.
The only differences between the Abbott and Direct Access Diagnostics devices are the name, the packaging and labeling format, and a modification to the labeled time to result requirement. Although some positive results may be seen as soon as 3 minutes from the start of the assay, customers are instructed to read the results when the Test Timer turns pink/red (approximately 5 minutes from beginning the test). A comparison of Similarities and Differences can be found in Table 1, page 9.
3
Table 1 Substantial Equivalence Similarities and Differences
| COMPARATORS | ADVISOR ONE-STEP
PREGNANCY TEST
(SUBJECT) | FACT PLUS ONE STEP
PREGNANCY TEST
(PREDICATE) |
|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------|
| Visual Result Presentation
Positive Signal
Negative Signal | Plus (+) Sign ·
Minus (-) Sign | Plus (+) Sign
Minus (-) Sign |
| Urine Collection & Mode of
Addition | Direct Urine Stream | Direct Urine Stream |
| Analyte
hCG | Same | Same |
| Specimen Type
Human Urine | Same | Same |
| Intended Use
Home Pregnancy Test | Same | Same |
| Technology
Qualitative - sandwich
colloidal particle
immunoassay | Same | Same |
| Time to Assay Result | 5 minutes
(some positives seen in 3
minutes) | 3 minutes
(some positives seen in 1
minute) |
| Components
Single unit test device (all
reagents contained on a
test strip within) | Same | Same |
| End of Assay
Color Change | Yes - Test Timer
Shows adequate sample
Wait to read results | Yes *
Do not wait for signal
before reading results |
| Strip Chemistry
Conjugate - Monoclonal
Anti-αhCG Antibody | Same | Same |
| Patient Bar
Polyclonal Anti-βhCG
Antibody | Same | Same |
| Control Bar
Polyclonal Anti-βhCG
Antibody and Polyclonal
Anti-Mouse | Same | Same |
| Consumer Use
Accuracy | 98% | 98% |
| Laboratory Use
Accuracy | 100% | 100% |
- Do not need to wait for signal before reading results
4
Performance Data
Accuracy testing was perfomed by Advanced Care Products using hCG-positive and hCG-negative female clinical urine specimens across three different lots of the Abbott device. which is currently marketed under the brand name of FactPLUS® One Step Pregnancy Test.
The device correctly identified 50/50 hCG-positive and 50/50 hCG-negative specimens. Tests were read immediately after the Test Timer turned pink fed, approximately 5 minutes after the start of the test. The hCG-positive samples were confirmed to be positive with the Hybritech ICON pregnancy test. The hCG-negative specimens were confirmed to be negative with the FactPLUS® Cup and Dropper Pregnancy Test. At three minutes agreement was 100% with the ICON and FactPLUS devices.
Consumer Testing
A clinical study was conducted to verify that consumers could obtain accurate test results when using the Abbott manufactured device according to the provided instructions. The consumer population consisted of 149 female volunteers recruited from a central New Jersey location. The volunteers were between the ages of 18 to 45, from various income, educational and employment backgrounds. Correct results were obtained by one hundred forty six (146) of one hundred forty nine (149) subjects for an overall accuracy of 98%. Subjects reported little difficulty with understanding the test instructions. Ninety-two percent reported that the instructions were "very easy to understand" and all subjects (100%) indicated that the instructions were "somewhat" or "very easy to understand.
Conclusion
The ABBOTT Advisor One-Step Pregnancy Test is substantially equivalent, and is in fact the same device as the FactPLUS® One Step Pregnancy Test, distributed by Direct Access Diagnostics. Laboratory testing indicates accuracy of 100%, sensitivity and specificity of 100% each.
Results of consumer clinical testing demonstrated that the Abbott device can be performed and correctly interpreted by consumers with an overall accuracy rate of 98%.
Prepared and Submitted January 8, 1997 by:
Abbott Laboratories Karen L. Gates ADD Regulatory Affairs Abbott Park, IL. 60064