(34 days)
currently marketed Fact PLUS Pregnancy . Test and Fact PLUS One Step Pregnancy Test
Not Found
No
The device description details a purely chemical and physical process for detecting hCG, with no mention of computational analysis, algorithms, or learning processes.
No
This device is an in vitro diagnostic immunoassay used to detect hCG in urine for pregnancy detection, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an over-the counter in vitro diagnostic immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG), in urine." It also mentions it is "indicated for consumer use to detect pregnancy as early as first day of a missed period," which is a diagnostic purpose.
No
The device description clearly outlines a physical, disk-shaped device with test chemistries and plastic components, indicating it is a hardware-based in vitro diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "over-the counter in vitro diagnostic immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG), in urine."
- Device Description: The description details how the device works by analyzing a biological sample (urine) to detect a specific analyte (hCG) using chemical reactions on a test strip. This is a hallmark of in vitro diagnostics.
- Performance Studies: The document describes laboratory and clinical studies conducted to evaluate the device's performance (accuracy, sensitivity, specificity) using biological specimens. This is a requirement for IVD devices.
The term "in vitro diagnostic" means that the device is used to examine specimens taken from the human body (in this case, urine) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Fact PLUS Pregnancy Test fits this definition perfectly as it detects hCG in urine to determine pregnancy.
N/A
Intended Use / Indications for Use
The modified Fact PLUS Pregnancy Test (Cup and Dropper) is an over-the counter in vitro diagnostic immunoassav intended for the qualitative detection of human chorionic gonadotropin (hCG), in urine. A labeling modification to the currently marketed Fact PLUS® Pregnancy Test enables the test results to be read in three minutes or less without altering the accuracy, sensitivity or specificity of the test.
The Fact PLUS Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of a missed period, any time of the day. Negative test results are confirmed after three minutes, some positives results can be read as soon as one minute.
Product codes
Not Found
Device Description
The modified Fact PLUS Pregnancy Test is a disk-shaped ("Test Disk") device constructed of two pieces of molded plastic. The test chemistries are coated on a test strip housed within the test disk. The test strip contains three reactive sites: a conjugate site, an antibody site and a control site. Three openings on the upper surface of the test disk correspond to these sites: "Urine Well," "Result Window," "Control Window" (CW) respectively.
When urine is added via the Urine Well it wets the conjugate (anti-α hCG antibody) mobilizing it. If hCG molecules are present in the urine specimen, an hCG/conjugate complex is formed. This complex and any remaining unbound coniuqate migrate along the strip attaching to the anti-8 hCG antibody contained on the vertical bar (positive) and also to the polyclonal antibodies on the intersecting horizontal bar (negative) causing a pink reaction. The appearance of pink color on the horizontal and vertical bars forms the "plus" sign or positive "pregnant" result.
When no hCG molecules are present in the urine specimen, the conjugate remains unbound and attaches only to the horizontal or "minus" bar causing it to turn pink. The appearance of only one pink horizontal bar constitutes the negative or ("not pregnant") result.
The urine flow continues on to the Control Window where it activates a special dye causing a red color to appear. The red color in the CW tells the user the that enough urine was added. It is can also play an important role in helping the Consumer Service representatives on our toll free number to evaluate consumer reported problems. It takes approximately five minutes for the urine to reach the Control Window. The appearance of a "plus" or a "minus" in the Result Window however, appears sooner usually within three minutes or less. Some positive results can appear as soon as one minute. The appearance of a plus or minus in the Result Window and red color in the Control Window are the built-in controls which indicate the test chemistries worked properly and that a sufficient volume of urine was added.
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 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was demonstrated in laboratory validation testing. Fact PLUS Pregnancy Test when performed according to the modified instructions was compare to the currently marketed Fact PLUS Pregnancy Tests for accuracy specificity, and sensitivity.
Percent laboratory accuracy was determined by testing hCG-positive and hCGnegative female clinical urine specimens across three different lots of Fact PLUS Pregnancy Test and one lot of Fact PLUS One Step. Data compared test results read according to the modified labeling instructions (three minutes) to test results read according to the current labeling instructions (End of Test Window /approximately 5 minutes). There was 100% agreement for all four lots at the three minute and five minute time frames.
A single-blind, consumer, clinical study was conducted to verify that consumers could obtain accurate test results when performing the Fact PLUS Pregnancy test and reading the results according to the modified directions. The consumer population consisted of 150 evaluable female volunteers recruited form a Central New Jersey location. On hundred and fifty-two subiects had been enrolled, however two subjects were dropped from the study for protocol violations. The participants were between 18 to 45 years of age, from various income levels, and educational and employment backgrounds.
Subjects were provided with a randomized hCG positive or hCG negative urine sample, the Fact Pregnancy Test and the modified instructions. All subjects who tested positive specimens recorded the results as positive and all subjects who tested negative specimens recorded the results as negative. The overall consumer accuracy rating was 100% for this study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Laboratory accuracy: 100% agreement for all four lots at the three minute and five minute time frames for hCG-positive and hCG-negative female clinical urine specimens.
Consumer accuracy: 100% overall accuracy rating for 150 evaluable female volunteers.
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.
currently marketed Fact PLUS Pregnancy . Test and Fact PLUS One Step Pregnancy 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.
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
Direct Access Diagnostics Division Premarket Notification [510(k)] FactPlus® Pregnancy Test (modification) NOV 1 8 1996
APPENDIX
510(k) SUMMARY
.
1
Image /page/1/Picture/0 description: The image shows the logo for Direct Access Diagnostics. The logo consists of a stylized letter D with an arrow pointing to the right, followed by the words "DIRECT ACCESS" in a bold, sans-serif font. Below the words "DIRECT ACCESS" is the word "DIAGNOSTICS" in a smaller, sans-serif font.
510(k) SUMMARY per 21 CFR 807.92(c)
Fact PLUS Pregnancy Test Trade name Consumer Use Home Pregnancy Test Common name Human chorionic Gonadotropin (hCG) Test System Classification name
Statement
Information supporting claims of substantial equivalence, as defined under the Federal Food Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the reviewer, this summary is formatted in accordance with the Agency's final rule ... "510(k) Summaries and 510(k) Statements." (21CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
- Modified device name: Fact PLUS Pregnancy Test .
- Predicate device name(s): currently marketed Fact PLUS Pregnancy . Test and Fact PLUS One Step Pregnancy Test
Intended Use
The modified Fact PLUS Pregnancy Test (Cup and Dropper) is an over-the counter in vitro diagnostic immunoassav intended for the qualitative detection of human chorionic gonadotropin (hCG), in urine. A labeling modification to the currently marketed Fact PLUS® Pregnancy Test enables the test results to be read in three minutes or less without altering the accuracy, sensitivity or specificity of the test.
Indications
The Fact PLUS Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of a missed period, any time of the day. Negative test results are confirmed after three minutes, some positives results can be read as soon as one minute.
Safety
Home pregnancy tests for detection of hCG in urine have been safely used and in commercial distribution for over twenty years. In vitro diagnostic hCG urine tests which do not come in contact with the body are not generally associated with safety issues. Home-use pregnancy tests are categorized as "waived" status under the 1988 Clinical Laboratory and Improvement Amendment (CLIA).
2
510(k) SUMMARY (continued)
Device Description
The modified Fact PLUS Pregnancy Test is a disk-shaped ("Test Disk") device constructed of two pieces of molded plastic. The test chemistries are coated on a test strip housed within the test disk. The test strip contains three reactive sites: a conjugate site, an antibody site and a control site. Three openings on the upper surface of the test disk correspond to these sites: "Urine Well," "Result Window," "Control Window" (CW) respectively.
When urine is added via the Urine Well it wets the conjugate (anti-α hCG antibody) mobilizing it. If hCG molecules are present in the urine specimen, an hCG/conjugate complex is formed. This complex and any remaining unbound coniuqate migrate along the strip attaching to the anti-8 hCG antibody contained on the vertical bar (positive) and also to the polyclonal antibodies on the intersecting horizontal bar (negative) causing a pink reaction. The appearance of pink color on the horizontal and vertical bars forms the "plus" sign or positive "pregnant" result.
When no hCG molecules are present in the urine specimen, the conjugate remains unbound and attaches only to the horizontal or "minus" bar causing it to turn pink. The appearance of only one pink horizontal bar constitutes the negative or ("not pregnant") result.
The urine flow continues on to the Control Window where it activates a special dye causing a red color to appear. The red color in the CW tells the user the that enough urine was added. It is can also play an important role in helping the Consumer Service representatives on our toll free number to evaluate consumer reported problems. It takes approximately five minutes for the urine to reach the Control Window. The appearance of a "plus" or a "minus" in the Result Window however, appears sooner usually within three minutes or less. Some positive results can appear as soon as one minute. The appearance of a plus or minus in the Result Window and red color in the Control Window are the built-in controls which indicate the test chemistries worked properly and that a sufficient volume of urine was added.
Substantial Equivalence
The modified Fact PLUS Pregnancy Test is substantially equivalent to the marketed version of Fact PLUS® Pregnancy Test with a labeling modification for reading the results sooner. Additionally modified Fact PLUS (Cup & Dropper) is substantially equivalent to Fact PLUS® One Step (Direct) Pregnancy test which also provides results within 3 minutes.
The proposed and the marketed devices have the same intended use, performance characteristics, and utilize the same chemistries, materials, and test analyte. All three pregnancy tests can be used the first day of missed period, at any time of day.
3
510(k) SUMMARY_(continued)
Performance Data
Substantial equivalence was demonstrated in laboratory validation testing. Fact PLUS Pregnancy Test when performed according to the modified instructions was compare to the currently marketed Fact PLUS Pregnancy Tests for accuracy specificity, and sensitivity.
Percent laboratory accuracy was determined by testing hCG-positive and hCGnegative female clinical urine specimens across three different lots of Fact PLUS Pregnancy Test and one lot of Fact PLUS One Step. Data compared test results read according to the modified labeling instructions (three minutes) to test results read according to the current labeling instructions (End of Test Window /approximately 5 minutes). There was 100% agreement for all four lots at the three minute and five minute time frames.
Consumer Testing
A single-blind, consumer, clinical study was conducted to verify that consumers could obtain accurate test results when performing the Fact PLUS Pregnancy test and reading the results according to the modified directions. The consumer population consisted of 150 evaluable female volunteers recruited form a Central New Jersey location. On hundred and fifty-two subiects had been enrolled, however two subjects were dropped from the study for protocol violations. The participants were between 18 to 45 years of age, from various income levels, and educational and employment backgrounds.
Subjects were provided with a randomized hCG positive or hCG negative urine sample, the Fact Pregnancy Test and the modified instructions. All subjects who tested positive specimens recorded the results as positive and all subjects who tested negative specimens recorded the results as negative. The overall consumer accuracy rating was 100% for this study.
Conclusion
The Fact PLUS Pregnancy Test with modified directions has been shown to be substantially equivalent to the currently marketed Fact PLUS® and the Fact PLUS® One Step Pregnancy Test in laboratory validation testing demonstrating 100% agreement for accuracy, sensitivity, specificity. Additionally, consumer testing demonstrated that the FactPLUS Pregnancy Test can be performed according to the modified directions and correctly interpreted by consumers with an overall accuracy rating of 100%.