(127 days)
No
The device description details a standard immunochromatographic assay based on chemical reactions and visual interpretation of lines, with no mention of computational analysis, algorithms, or learning processes.
No
Explanation: A therapeutic device is used to treat or prevent a disease or condition. This device is a diagnostic tool designed to detect pregnancy, not to treat or prevent any condition.
Yes
The device qualitatively identifies the elevated level of Human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy, which is a diagnostic purpose.
No
The device description clearly outlines a physical, immunochromatographic test strip with membranes, absorbent pads, and chemical reagents, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative identification of the elevated level of Human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy." This is a diagnostic test performed on a biological sample (urine) outside of the body.
- Device Description: The description details an "hCG assay" based on "immunochromatographic technology." This is a common method used in IVD tests to detect specific substances in biological samples.
- Sample Type: The test uses a "urine sample," which is a biological specimen.
- Purpose: The purpose is to "aid in the determination of pregnancy," which is a diagnostic purpose.
The fact that it is for "over-the-counter consumer use" and performed at "Home" does not change its classification as an IVD. Many IVDs are designed for home use.
N/A
Intended Use / Indications for Use
The BE CERTAIN™ Home Pregnancy Test is intended for the qualitative identification of the elevated level of Human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter consumer use.
Product codes
LCX
Device Description
The BE CERTAIN™ Home Pregnancy Test is an hCG assay, comprising of a rapid one-step test, based on an immunochromatographic technology. The test is made up of a membrane with an absorbent pad overlapping a strip of fiber glass paper that is impregnated with a lyophilized colloidal conjugate of gold particles and monoclonal solid phase antibodies to hCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into the device and proceeds through the absorbent pad, then laterally onto a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the hCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-hCG monoclonal antibody affixed on the test zone ("T") will bind the hCG-gold conjugate complex, forming a pink line ("T"). All samples will cause a pink colored line to appear in the control zone ("C"). This line is formed by the binding of the polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly. In less than 5 minutes, levels of hCG as low as 25mlU/ml can be detected.
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 consumer / Home
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)
SENSITIVITY/DETECTION LIMIT DATA
Study Type: Sensitivity/Detection Limit
Sample Size: 30 different non-pregnant male or female subjects (for urine samples), 5 samples at each concentration of hCG.
Key Results: The sponsor claims a detection limit of 25 mIU/ml for the BE CERTAIN™ Home Pregnancy Test. At 25 mIU/ml, 5 out of 5 samples tested positive.
SPECIFICITY DATA INCLUDING LH, FSH, AND TSH
Study Type: Specificity
Sample Size: 45 different normal, non-pregnant subjects (for urine samples).
Key Results: No cross-reactivity was observed with physiological concentrations of hLH, hFSH, and hTSH. When 10 mIU/ml hCG was added to samples with hLH, hFSH, and hTSH, no positive readings were observed. All samples spiked with 50 mIU/ml hCG (and hLH, hFSH, or hTSH) showed a positive reading, as expected.
INTERFERING SUBSTANCES DATA
Study Type: Interference
Sample Size: Not explicitly stated, but 3 samples were used for each analyte and pH level.
Key Results: No interference was observed by the tested exogenous compounds (Acetaminophen, Aspirin, Ampicillin, Tetracycline, Caffeine, Ascorbic Acid, Glucose, Protein, Albumin, Bilirubin, Hemoglobin, Triglyceride) and pH ranges between 3-10 did not adversely affect the test, producing expected results.
COMPARISON STUDY USING THE DIP METHOD
Study Type: Comparison Study (Concordance, Sensitivity, Specificity)
Sample Size: 100 normal, non-pregnant females (for spiked human urine samples)
Key Results:
- Concordance of BE CERTAIN™ (End User) vs. BE CERTAIN™ (Prof. User): 100% (95% CI: 96% - 100%). Sensitivity: 100% (95% CI: 94% - 100%). Specificity: 100% (95% CI: 91% - 100%).
- Concordance of BE CERTAIN™ (End User) vs. E.P.T.® (Prof. User): 99% (95% CI: 95% - 100%). Sensitivity: 98.3% (61/62) (95% CI: 91% - 100%). Specificity: 100% (95% CI: 91% - 100%).
Conclusion: Strong concordance between end-user and professional-user results, and with the predicate device.
COMPARISON STUDY USING THE URINE DROPSTREAM METHOD
Study Type: Comparison Study (Concordance, Sensitivity, Specificity)
Sample Size: 50 normal, non-pregnant females (for spiked human urine samples)
Key Results:
- Concordance of BE CERTAIN™ (End User, Urine DropStream) vs. E.P.T.® (Prof. User, Urine Dip): 100% (95% CI: 93% - 100%). Sensitivity: 100% (95% CI: 88% - 100%). Specificity: 100% (95% CI: 86% - 100%).
Conclusion: The device produced equivalent results when using the urine dropstream method compared to the dip urine method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity/Detection Limit: 25 mIU/ml (95% of test results are positive at this concentration)
Comparison Study (Dip Method):
BE CERTAIN™ (End User) vs. BE CERTAIN™ (Prof. User):
- Concordance: 100%
- Sensitivity: 100%
- Specificity: 100%
BE CERTAIN™ (End User) vs. E.P.T.® (Prof. User):
- Concordance: 99%
- Sensitivity: 98.3% (61/62)
- Specificity: 100%
Comparison Study (Urine Dropstream Method):
BE CERTAIN™ (End User, Urine DropStream) vs. E.P.T.® (Prof. User, Urine Dip):
- Concordance: 100%
- Sensitivity: 100%
- Specificity: 100%
Predicate Device(s)
Reference Device(s)
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
510(k) SUMMARY (As Required by IV. Section 807.92(c)
NOV 2 3 2005
OWNER'S NAME [807.92(a)(1)] (A)
| Owner's Name: | Victor J. Santos
President |
|-----------------|------------------------------------------|
| Company: | Natureplex, LLC |
| Address: | 3791 Airpark Street
Memphis, TN 38118 |
| Phone: | (866) 323-0107 |
| FAX: | (901) 323-2088 |
| Contact Person: | Victor J. Santos |
| Date Prepared: | September 15, 2005 |
NAME OF THE DEVICE [807.92(a)(2)] (B)
BE CERTAINTM Home Pregnancy Test Trade Name: hCG Pregnancy Test Common Name: Classification Name: FDA Product Code: LCX Kit. Test. Pregnancy, hCG, Over-the-Counter
LEGALLY MARKETED DEVICE [807.92(a)(3)] (C)
Substantial equivalence is being claimed with the following legally marketed device: E.P.T. Pregnancy Test (K# 033658).
DESCRIPTION OF THE DEVICE [807.92(a)(4)] (D)
The BE CERTAIN™ Home Pregnancy Test is an hCG assay, comprising of a rapid one-step test, based on an immunochromatographic technology. The test is made up of a membrane with an absorbent pad overlapping a strip of fiber glass paper that is impregnated with a lyophilized colloidal conjugate of gold particles and monoclonal solid phase antibodies to hCG. Other absorbent pads at the end of the assay absorb excess sample fluid. The urine sample is introduced into the device and proceeds through the absorbent pad, then laterally onto a chromatographic membrane. As it contacts the membrane, the sample dissolves the lyophilized conjugate. In a reactive sample, the hCG antigen will attach to the antibodies in the colloidal solution. As the conjugate moves forward on the membrane, anti-hCG monoclonal antibody affixed on the test zone ("T") will bind the hCG-gold conjugate complex, forming a pink line ("T"). All samples will cause a pink colored line to appear in the control zone ("C"). This line is formed by the binding of the polyclonal antibodies (Anti-mouse IgG) affixed onto the control zone to the sample-colloidal gold conjugate. Presence of this line indicates that the test has been carried out correctly. In less than 5 minutes, levels of hCG as low as 25mlU/ml can be detected.
1
INTENDED USE OF THE DEVICE [807.92(a)(5)] (E)
The BE CERTAIN™ Home Pregnancy Test is intended for the qualitative identification of the elevated level of Human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy. It is for over-the-counter consumer use.
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE AS (F) COMPARED TO PREDICATE DEVICE [807.92(a)(5)]
The BE CERTAIN™ Home Pregnancy Test is substantially equivalent to the E.P.T. 8 Pregnancy Test [#K033658] based on the following characteristics:
| ITEM | BE CERTAIN™ Home
Pregnancy Test | E.P.T.® Pregnancy Test |
|---------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended Use | Qualitative identification of
pregnancy hormone i.e.,
Human Chorionic
Gonadotrophin (hCG) | Qualitative identification of
pregnancy hormone i.e.,
Human Chorionic
Gonadotrophin (hCG) |
| Indications for Use | Determination of pregnancy | Determination of pregnancy |
| Target Population | Pregnant women | Pregnant women |
| Where Used | Home | Home |
| Formats Available | Casette | Casette |
| Sterility | Non-sterile | Non-sterile |
| Specimen Type | Human urine | Human urine |
| Antibodies | • Polyclonal anti-mouse IgG
• Anti-β-hCG antibody and
anti-α hCG monoclonal
antibody | • Polyclonal anti-mouse IgG
• Anti-β-hCG antibody and
anti-α hCG monoclonal
antibody |
| Cutoff | 25 mIU/ml | 25 mIU/ml |
| Storage Temperature | 4 – 30° C | 2 – 30° C |
| Read Time | 3 – 5 Minutes | 2 – 10 Minutes |
NON-CLINICAL PERFORMANCE DATA [807.92(b)(1)] AND (G) CONCLUSIONS FROM NON-CLINICAL TESTS [807.92(b)(3)]
SENSITIVITY/DETECTION LIMIT DATA (1)
To determine the sensitivity/detection limit of the BE CERTAIN™ Home Pregnancy Test, the analyte concentration of Human Chorionic Gonadotrophin (hCG) at which 95% of the test results are positive was determined. This was carried out by spiking human urine samples from 30 different non-pregnant male or female subjects with different concentrations of hCG. A total of five different samples at each concentration of hCG was blindly labeled and tested with the BE CERTAIN™ Home Pregnancy Test. The results of this study are presented in Table 1 below.
2
| hCG CONCENTRATION | POSITIVE | NEGATIVE |
|---|---|---|
| 0 mIU/ml | 0 of 5 | 5 of 5 |
| 12.5 mIU/ml | 1 of 5 | 4 of 5 |
| 18.75 mIU/ml | 3 of 5 | 2 of 5 |
| 25 mIU/ml | 5 of 5 | 0 of 5 |
| 50 mIU/ml | 5 of 5 | 0 of 5 |
| 100 mIU/ml | 5 of 5 | 0 of 5 |
Sensitivity/Detection Limit Data for the BE CERTAIN™ Home Pregnancy Table 1.
The sensitivity of the BE CERTAIN™ Home Pregnancy Test was tested by spiking thirty negative urine samples with varying concentrations of hCG. None of the samples (0%) for 0 mIU/ml of hCG had tested positive. Conversely, 1 out of 5 (20%) and 3 out of 5 (60%) for 12.5 mIU/ml and 18.75 mIU/ml of hCG, respectively, had tested positive. All (0070) for 12:5 mIU/ml, 50 mIU/ml, and 100 mIU/ml, and 100 mIU/ml had tested positive with the Samples (100%) 10125 Pregnancy Test. The sponsor claims a detection limit of 25 mIUml for the BE CERTAIN™ Home Pregnancy Test.
SPECIFICITY DATA INCLUDING LH, FSH, AND TSH (2)
To determine the specificity of the BE CERTAIN™ Home Pregnancy Test, in terms of its To determine the specifiery of concentration of Human Luteinizing Hornone Closs-Teach ity with mga physioisg - comone (hFSH), and Human Thyroid Stimulating (Incri), Trainan Fromers Samples from a total of 45 different normal, normal, normal, non-pregnant fromous (ITCPT), mailing with varying concentration of hLH, hFSH, and hTSH, with or without hCG. The results of this study are presented in Table 2 below.
| Table 2. Specificity Data for the BE CERTAIN™ Home Pregnancy Test. | |||||||
|---|---|---|---|---|---|---|---|
| HORMONES | 5 mls URINE | 5 mls URINE + | |||||
| 10 mIU/ml hCG | 5 mls URINE + | ||||||
| 50 mIU/ml hCG | |||||||
| (+) | (-) | (+) | (-) | (+) | (-) | ||
| hLH | 100 mIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 |
| 300 mIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 | |
| 500 mIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 | |
| hFSH | 100 mIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 |
| 300 mIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 | |
| 500 mIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 | |
| hTSH | 750 µIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 |
| 1,000 µIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 | |
| 1,250 µIU/ml | 0 of 5 | 5 of 5 | 0 of 5 | 5 of 5 | 5 of 5 | 0 of 5 |
Specificity Data for the BE CERTAIN™ Home Pregnancy Test. THIA 2
For the human urine samples spiked with hLH, hFSH, and hTSH at varying concentrations, none of the samples (0%) showed a positive reading with the BE
3
CERTAIN™ Home Pregnancy Test. Similarly, for the human urine + 10 mIU/ml hCG samples that were spiked with hLH, hFSH, and hTSH at varying concentrations, none of the samples (0%) showed a positive reading with the BE CERTAIN™ Home Pregnancy Test. Conversely, for the human urine + 50 mIU/ml hCG samples that were spiked with hLH, hFSH, and hTSH at varying concentrations, all samples (100%) showed a positive reading with the BE CERTAIN™ Home Pregnancy Test as would have been expected since the BE CERTAIN™ Home Pregnancy Test has been demonstrated to have a detection limit of hCG at 25 mIU/ml.
INTERFERING SUBSTANCES DATA (3)
To determine the interference by certain exogenous compounds, human urine samples from non-pregnant female or male subjects were spiked with prescription/OTC drugs. chemical analytes, biological analytes, as well as titrated for pH, and tested with the BE CERTAIN™ Home Pregnancy Test. The results of the analyte interfering study are presented in Table 3 below.
| ANALYTES | 5 mls URINE | 5 mls URINE + 50 mIU/ml hCG | ||
|---|---|---|---|---|
| (+) | (-) | (+) | (-) | |
| Acetaminophen (20 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Aspirin (20 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Ampicillin (20 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Tetracycline (20 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Caffeine (20 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Ascorbic Acid (20 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Glucose (2000 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Protein (2000 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Albumin (20 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Bilirubin (2 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Hemoglobin (1 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
| Triglyceride (800 mg/dL) | 0 of 3 | 3 of 3 | 3 of 3 | 0 of 3 |
Table 3: Analyte Interfering Data for the BE CERTAIN™ Pregnancy Test.
The results of the pH interfering study are presented in Table 4 below.
| Table 4:
pH | pH Interfering Data for the BE CERTAIN™ Pregnancy Test.
5 mls URINE | | 5 mls URINE +
50 mIU/ml hCG | |
|----------------|------------------------------------------------------------------------|--------|--------------------------------|--------|
| | (+) | (-) | (+) | (-) |
| pH 3 | 0 of 1 | 1 of 1 | 1 of 1 | 0 of 1 |
| pH 5 | 0 of 1 | 1 of 1 | 1 of 1 | 0 of 1 |
| pH 7 | 0 of 1 | 1 of 1 | 1 of 1 | 0 of 1 |
| pH 10 | 0 of 1 | 1 of 1 | 1 of 1 | 0 of 1 |
4
No interference was observed by the exogenous compounds tested above, as observed in this study using the BE CERTAIN™ Home Pregnancy Test. Further, human urine samples with pH ranges between 3-10 did not adversely affect the test and produced the expected results.
CLINICAL PERFORMANCE DATA [807.92(b)(2)] AND (H) CONCLUSIONS FROM CLINICAL TESTS [807.92(b)(3)]
COMPARISON STUDY USING THE DIP METHOD (1)
Spiked human urine samples from 100 normal, non-pregnant females were tested in order to determine the correlation of the new test, the BE CERTAIN™ Pregnancy Test, when used by subjects using a dip method, with that of the BE CERTAIN™ Pregnancy Test, when tested by a professional user, as well as with that of a reference standard, the E.P.T. Pregnancy Test (i.e., the predicate device; previously cleared under 510(k) #K033658) The results of this study are as follows:
Table 5. Concordance of BE CERTAIN™ Home Pregnancy Test (Tested by End User) Compared with BE CERTAIN™ Home Pregnancy Test (Tested by Professional User), Both Following a Urine Dip Method.
| BE CERTAIN™ (Prof. User) | ||||
|---|---|---|---|---|
| (+) | (-) | |||
| BE CERTAIN™ | ||||
| (End User) | (+) | 61 | 0 | 61 |
| (-) | 0 | 39 | 39 | |
| Total | 61 | 39 | 100 |
Based on the above 2x2 analysis, the Concordance of the BE CERTAIN™ Home Pregnancy Test when tested by the End User and the Professional User is 100/100= 100%, with a 95% confidence interval of 96% - 100%. The sensitivity of the BE CERTAIN™ Home Pregnancy Test is 61/61= 100%, with a 95% confidence interval of 94% - 100%. Finally, the Specificity of the BE CERTAIN™ Home Pregnancy Test is 39/39- 100%, with a 95% confidence interval of 91% - 100%.
Concordance of BE CERTAIN™ Home Pregnancy Test (Tested by End Table 6. User) Compared with E.P.T. Pregnancy Test (Tested by Professional User), Both Following a Urine Dip Method
| E.P.T.® (Prof. User) | ||||
|---|---|---|---|---|
| (+) | (-) | |||
| BE CERTAIN™ | ||||
| (End User) | (+) | 61 | 0 | 61 |
| (-) | 1 | 38 | 39 | |
| Total | 62 | 38 | 100 |
Based on the above 2x2 analysis, the Concordance of the BE CERTAIN™ Home Pregnancy Test when tested by the End User, as compared with the predicate device, the
Natureplex, LLC IV- 5 BE CERTAIN™ Home Pregnancy Test 510(k) / Amendment No. 4 - 11/14/05)
5
E.P.T. ® Pregnancy Test as tested by the Professional User is 99/100= 99%, with a 95% confidence interval of 95% - 100%. The sensitivity of the BE CERTAIN™ Home Pregnancy Test is 61/62= 98.3%, with a 95% confidence interval of 91% - 100%. Finally, the Specificity of the BE CERTAIN™ Home Pregnancy Test is 38/38= 100%, with a 95% confidence interval of 91% - 100%.
The above studies show that the BE CERTAIN™ Home Pregnancy Test, when used by either an end user or a professional user following a urine dip method have a strong concordance. Likewise, the BE CERTAIN™ Home Pregnancy Test has a strong concordance with the predicate device, the E.P.T. ® Pregnancy Test.
COMPARISON STUDY USING THE URINE DROPSTREAM (2) METHOD
Spiked human urine samples from 50 normal, non-pregnant females were tested in order to determine the correlation of the new test, the BE CERTAIN™ Pregnancy Test, when used by subjects using a urine dropstream method, with that of the reference standard, the E.P.T. Pregnancy Test (i.e., the predicate device; previously cleared under 510(k) #K033658). The results of this study are as follows:
- Table 7. Concordance of BE CERTAIN™ Home Pregnancy Test (Tested by End User Using a Urine DropStream Method) Compared with E.P.T." Pregnancy Test (Tested by Professional User Using a Urine Dip Method)
| E.P.T.® (Urine Dip) | |||
|---|---|---|---|
| (+) | (-) | ||
| BE CERTAIN | |||
| (Urine Stream) | 27 | 0 | 27 |
| (-) | 0 | 23 | 23 |
| Total | 27 | 23 | 50 |
Based on the above 2x2 analysis, the Concordance of the BE CERTAIN™ Home Pregnancy Test when tested by the End User using a urine dropstream method, as compared with the E.P.T.® Pregnancy Test (Tested by Professional User using a Urine Dip Method) is 50/50= 100%, with a 95% confidence interval of 93% - 100%. The sensitivity of the BE CERTAIN™ Home Pregnancy Test is 27/27= 100%, with a 95% confidence interval of 88% - 100%. Finally, the Specificity of the BE CERTAIN™ Home Pregnancy Test is 23/23= 100%, with a 95% confidence interval of 86% - 100%.
As expected, the BE CERTAIN™ Pregnancy Test, when tested using the urine dropstream method, had produced equivalent results with that of the dip urine method.
6
(1) OTHER INFORMATION [807.92(d)]
EXPECTED VALUES (1)
The BE CERTAIN™ Home Pregnancy Test is capable of detecting pregnancy by the first day of the missing period and no sooner.
CALIBRATION (2)
The BE CERTAIN™ Home Pregnancy Test is calibrated against the WHO 3rd International Standard for hCG.
QUALITY CONTROL (3)
The BE CERTAIN™ Home Pregnancy Test has built in Quality Control Features. After addition of the urine sample, these colored bands migrate along the membrane at the leading edge of the dye conjugate and are "removed" from the test strip completely.
When the test is complete, the end user will see a pink-purple colored band in the "C" area of the test strip on negative samples and a pink-purple colored band in the "T" and "C" area on positive samples. The appearance of the CONTROL ("C") band indicates that the test strip is performing properly and serves as a procedural internal control.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 3 2005
Mr. Victor J. Santos President Natureplex, LLC. 3791 Air Park Street Memphis, TN 38118
Re: K051963
Trade/Device Name: BE CERTAIN Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: November 16, 2005 Received: November 17, 2005
Dear Mr. Santos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510 (k) Number: K051963
Device Name:
BE CERTAIN Pregnancy Test
"Indications for Use": The BE CERTAIN Pregnancy Test is intended for the qualitative The DD CERTIFIN : Fregioned level of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. It is for over-thecounter consumer use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
x Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1
signature
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051963