(29 days)
Not Found
No
The device description and performance studies focus on a traditional lateral flow immunoassay, which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation. There is no mention of any computational analysis or algorithms.
No.
This device is an in vitro diagnostic device used to detect pregnancy, not to treat or prevent a medical condition.
Yes
The device is described as a "rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine" and is "designed to aid early detection of pregnancy". Detecting a biomarker (hCG) to aid in the diagnosis of a condition (pregnancy) classifies it as a diagnostic device.
No
The device description clearly outlines physical components like a conjugate pad, nitrocellulose membrane, and a test strip, indicating it is a hardware-based immunoassay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine". This is a test performed in vitro (outside the body) on a biological specimen (urine) to provide information about a physiological state (pregnancy).
- Device Description: The description details the components and mechanism of the test, which involves chemical reactions between antibodies and hCG in the urine sample on a test strip. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes studies involving testing urine samples to determine the device's performance (sensitivity, reproducibility, method comparison, lay-user study). These are standard evaluations for in vitro diagnostic devices.
- Predicate Device: The mention of a predicate device (K990578; OSOM® Card II hCG-Urine Test) which is also an IVD, further supports that this device falls under the same category.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Detecting hCG in urine to determine pregnancy fits this definition.
N/A
Intended Use / Indications for Use
The Chemtrue® hCG Pregnancy Urine Midstream Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Midstream. The test is designed to aid early detection of pregnancy by home users. The device is intended for Over-The-Counter (OTC) Use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
Test principal: The device employs lateral flow immunoassay technology for detection of human chorionic gonadotropin (hCG) in urine. Monoclonal goat anti-hCG antibodies are pre-striped in the nitrocellulose membrane on the test region (T line) and goat antibodies on the control region (C line). During testing, the urine/serum specimen reacts with the conjugate pad (It contains colloidal gold particles conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG) located just beneath the sample pad and above the membrane of the test strip. The specimen migrates upward on the membrane by capillary action to react with the antibodies on the membrane. If the hCG concentration in the specimen is at or above the designated detection limit, a red colored line at the test region will be present indicating a positive result, while its absence indicates a negative result. The control line (C line) serves as an internal quality control. The control line should always appear, regardless of the hCG concentration of the test specimen, and the C line is an indicator that sufficient sample volume has been added to the test device and the sample has correctly migrated up the test strip.
The device is designed in Midstream format. Each device consists of one (1) individual test strip and each test strip in the device consists of:
-
- A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
-
- A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line). Presence of this line indicates that the test is performed correctly. A test result is read at three (3) minutes and the cut-off of the device is 20 mIU/mL hCG.
The Midstream Test kit consists of one test device in a foil pouch and a package insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
The summary mentions that participants in the method comparison study had an age range from 22 to 39 years and in the lay user study, 100 women with diversified education backgrounds and ages ranging from 22-39 years participated.
Intended User / Care Setting
home users / Over-The-Counter (OTC) 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
Sensitivity (Cutoff Characteristics) Study:
- Sample size: 15 tests per hCG concentration level per lot, 3 lots, total of 75 tests per hCG concentration.
- Data source: Spiked hCG urine pool from non-pregnant donors. hCG was traceable to WHO 5th IS (07/364).
- Annotation protocol: Controls were blind coded. Five (5) replicates were tested at each hCG control level by three (3) operators using simulated midstream test method.
Reproducibility (Precision) Study:
- Sample size: Not explicitly stated as a single number, but involves testing across three (3) POL sites, by nine (9) operators (three per site), with three (3) lots over five (5) nonconsecutive days.
- Data source: Blind coded controls with hCG spiked at concentrations of 0, 10, 15, 20, 25, 30, 35, and 40 mIU/mL in urine. Controls were calibrated against WHO 5th IS (07/364).
- Annotation protocol: Every device was tested by using simulated midstream method and interpreted by the same operator each day.
Method Comparison Study:
- Sample size: 300 urine samples (100 women per hospital presenting at three (3) hospitals).
- Data source: Urine samples collected from women suspected to be pregnant (approximately half) or in early/later first trimester of pregnancy. Samples collected at various times throughout the day.
- Annotation protocol: All subjects performed self-test. Samples also collected for tests by healthcare professionals (HCPs) with the proposed Chemtrue® hCG Pregnancy Urine Midstream Test and the predicate device. Each specimen was evenly split into three aliquots with a unique set of blind codes.
OTC Lay-user Study:
- Sample size: 100 women.
- Data source: Natural and spiked urine samples. Negative urine sample pools were spiked with 10, 15 and 25 mIU/mL hCG. Each concentration sample pool was split into 100 individual vials.
- Annotation protocol: All aliquots were blindly labeled by the Clinical Research Coordinator. 100 female participants tested their own urine and one masked sample using midstream method per the English package insert. Aliquots of the participants' urine and spiked urine were tested by HCPs using dip method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Sensitivity (Cutoff Characteristics):
- Study type: Analytical sensitivity study.
- Sample size: 15 tests at each hCG concentration (0, 10, 15, 20, 40, 80 mIU/mL) per lot, for 3 lots.
- Key results:
- 0 mIU/mL hCG: 0/15 positive results (all lots).
- 10 mIU/mL hCG: 0/15 positive results (all lots).
- 15 mIU/mL hCG: 3/15 positive results (1 positive per lot).
- 20 mIU/mL hCG (Cutoff): 15/15 positive results (5 positive per lot).
- 40 mIU/mL hCG: 15/15 positive results (5 positive per lot).
- 80 mIU/mL hCG: 15/15 positive results (5 positive per lot).
- Conclusion: Confirmed claimed cutoff level of 20 mIU/mL and demonstrated consistency between lots.
2. Reproducibility (Precision) Study:
- Study type: Reproducibility/Precision study.
- Sample size: Conducted in three (3) POL sites by nine (9) operators (three per site) with three (3) lots over five (5) nonconsecutive days. Each concentration tested 9 times per site.
- Key results:
- 0 mIU/mL hCG: 0 positives / 27 total across 3 sites.
- 10 mIU/mL hCG: 0 positives / 27 total across 3 sites.
- 15 mIU/mL hCG: 3 positives / 27 total across 3 sites.
- 20 mIU/mL hCG: 27 positives / 27 total across 3 sites.
- 25 mIU/mL hCG: 27 positives / 27 total across 3 sites.
- 30 mIU/mL hCG: 27 positives / 27 total across 3 sites.
- 35 mIU/mL hCG: 27 positives / 27 total across 3 sites.
- Conclusion: Demonstrated consistent functional performance between sites.
2. Analytical specificity:
- Cross-reactivity: No interference observed for 1000 IU/L FSH, 500IU/L LH, or 1000 IU/L TSH.
- Exogenous compounds: No interference observed from 17 listed exogenous compounds at specified concentrations for both negative and positive hCG urine samples.
- Beta-core hCG fragment: No interference observed from ß-core hCG fragment up to 1,000,000 pmol/mL.
- pH effect: No interference observed over the pH range from 2.0 to 9.0.
- Specific gravity (SG) effect: No interference observed over the SG range from 1.003 to 1.030.
- High dose / hook effect: No hook effect observed with hCG concentrations up to 500 IU/mL in urine.
3. Method Comparison Study Data Summary:
- Study type: Comparison with predicate device.
- Sample size: 300 urine samples from 100 women per hospital across 3 hospitals.
- Key results:
- Chemtrue® hCG Midstream tested by Professionals vs. Predicate Device - OSOM® Card hCG-Urine Test:
- 150 Positive (Chemtrue) vs. 150 Positive (Predicate)
- 0 Positive (Chemtrue) vs. 150 Negative (Predicate)
- 0 Negative (Chemtrue) vs. 0 Positive (Predicate)
- 150 Negative (Chemtrue) vs. 0 Negative (Predicate)
- Agreement: 100%.
- Chemtrue® hCG Midstream tested by Professionals vs. Predicate Device - OSOM® Card hCG-Urine Test:
- Conclusion: Agreement of Chemtrue® hCG Pregnancy Urine Midstream Test with the predicate device is 100%.
4. OTC lay-user Study:
- Study type: Lay-user study, comparing lay-user results with HCP results.
- Sample size: 100 women.
- Key results:
- Comparison of Midstream Method by OTC lay-user with Dip Method by HCPs (N=100):
- Positive (Lay-user) vs. Positive (HCPs): 55
- Positive (Lay-user) vs. Negative (HCPs): 0
- Negative (Lay-user) vs. Positive (HCPs): 0
- Negative (Lay-user) vs. Negative (HCPs): 45
- Total Agreement: 100%.
- Cut-off testing results by lay-users using simulated midstream method vs HCPs using dip method:
- 10 mIU/mL hCG: Lay-users 0/33 positive, HCPs 0/33 positive.
- 15 mIU/mL hCG: Lay-users 2/34 positive, HCPs 1/34 positive.
- 25 mIU/mL hCG: Lay-users 33/33 positive, HCPs 33/33 positive.
- Comparison of Midstream Method by OTC lay-user with Dip Method by HCPs (N=100):
- Conclusion: Further confirmed cutoff. Demonstrated equivalency of Midstream testing method and dip method and suitability for home use by lay persons, with 100% agreement between OTC lay-users and healthcare professionals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity (Cutoff): 20 mIU/mL. All 15 tests at the 20 mIU/mL cutoff level were positive across three lots (100% detection at cutoff).
- Agreement with predicate device: 100% (Method Comparison Study, N=300).
- Agreement between OTC lay-users and healthcare professionals: 100% (OTC lay-user Study, N=100).
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.
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
510(k) Summary
AS REQUIRED BY 21 CFR 807.92(c)
510(k) number: K131931
Submitter's Name: A.
Chemtron Biotech, Inc. Address: 8370 Juniper Creek Lane, San Diego, California, 92126 Telephone number: (858) 530-2868 Contact person: Jane Zhang Prepared on July 25, 2013
JUL 26 2013
B. Name of the device (Trade/Proprietary Name):
Chemtrue® hCG Pregnancy Urine Midstream Test Classification: Class II.
C. Predicate Kit:
Predicate device name(s) and 510(k) number(s):
| Predicate Device Name | 510(k) k number |
|---|---|
| OSOM® Card II hCG-Urine Test | K990578 |
D. Indications for Use:
The Chemtrue® hCG Pregnancy Urine Midstream Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Midstream. The test is designed to aid early detection of pregnancy by home users. The device is intended for Over-The-Counter (OTC) Use.
E. Substantial Equivalence Information:
The Chemtrue® hCG Pregnancy urine Midstream Test is substantially equivalent to other tests currently on the market.
In comparison with the predicate, the Chemtrue® hCG Pregnancy Urine Midstream Test is similar to the predicate(s) with regard to the technology principle, test method, detection limit, sample matrix and performance, etc. The candidate device and the predicates are both visuallyread single use devices. Comparison with the predicate devices is outlined below:
| Item | SIMILARITIES AND DIFFERENCES | |
|---|---|---|
| Proposed Device | Predicate Device | |
| Chemtrue® hCG Pregnancy Urine | ||
| Midstream Test | OSOM® Card II hCG- | |
| Urine Test K990578 | ||
| Intended Use | A rapid qualitative immunoassay for rapid | |
| determination of human chorionic | ||
| gonadotropin (hCG) to aid in the early | Same |
1
| detection of pregnancy | ||
|---|---|---|
| Technology principle | Colloidal gold conjugate lateral-flow | |
| immunoassay | Same | |
| Specimen matrix | Human urine | Same |
| Result Interpretation | Visually-read line intensity | Same |
| Sensitivity | 20 mIU/mL | Same |
| Quality Control | Built-in Internal Control | Same |
| Read time | Read the results at 3 minutes. | Same |
| Indication of Use | For Over-The-Counter (OTC) use | For prescription use |
| Device format | Midstream | Cassette |
| Storage | 4°C - 30°C | 15°C — 30°C |
| Traceability | WHO International Standard 5th Edition | WHO International |
| Standard 3rd Edition |
CONCLUSION: All the nonclinical and clinical study data in this 510(k) summary demonstrates that the Chemtrue® hCG Pregnancy Urine Midstream Test is substantially equivalent to the legally marketed devices.
ய் Device Description:
Test principal: The device employs lateral flow immunoassay technology for detection of human chorionic gonadotropin (hCG) in urine. Monoclonal goat anti-hCG antibodies are pre-striped in the nitrocellulose membrane on the test region (T line) and goat antibodies on the control region (C line). During testing, the urine/serum specimen reacts with the conjugate pad (It contains colloidal gold particles conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG) located just beneath the sample pad and above the membrane of the test strip. The specimen migrates upward on the membrane by capillary action to react with the antibodies on the membrane. If the hCG concentration in the specimen is at or above the designated detection limit, a red colored line at the test region will be present indicating a positive result, while its absence indicates a negative result. The control line (C line) serves as an internal quality control. The control line should always appear, regardless of the hCG concentration of the test specimen, and the C line is an indicator that sufficient sample volume has been added to the test device and the sample has correctly migrated up the test strip.
The device is designed in Midstream format. Each device consists of one (1) individual test strip and each test strip in the device consists of:
-
- A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG.
-
- A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line). Presence of this line indicates that the test is performed correctly. A test result is read at three (3) minutes and the cut-off of the device is 20 mIU/mL hCG.
The Midstream Test kit consists of one test device in a foil pouch and a package insert.
2
Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| LCX | Class II | 21 CFR 862.1155, Human Chorionic | |
| Gonadotropin (hCG) test system | 75 Clinical Chemistry | ||
| (CH) |
Performance Characteristics:
Chemtron Biotech, Inc. has reviewed the FDA guidance documents "Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs) - Document Issued on: November 6, 1996", "Guidance for Over-The-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s issued on July 22, 2000, as well as CFR809.10 labeling regulations and the applicable studies listed in the notification were conducted, including the design of draft labeling and package inserts. The result read time for all the studies was three (3) minutes.
-
- Sensitivity (Cutoff Characteristics): Three (3) lots were used for the study with spiked hCG urine pool from non-pregnant donors. The hCG was traceable to WHO 5th IS (07/364) at the concentrations of 0, 10,15,20,40 and 80 mIU/mL. The controls were blind coded. Separate sets of the blind codes were assigned. Five (5) replicates were tested at each hCG control level by three (3) operators using simulated midstream test method. The results are summarized in table 1 below:
| hCG Conc.
(mIU/mL) | # of Tests | Lot 1 | | Lot 2 | | Lot 3 | | # of
Positives |
|-----------------------|------------|-------|---|-------|---|-------|---|-------------------|
| 0 | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 10 (-50% Cutoff) | 15 | 0 | 5 | 0 | 5 | 0 | 5 | 0/15 |
| 15 (-25% Cutoff) | 15 | 1 | 4 | 1 | 4 | 1 | 4 | 3/15 |
| 20 (Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 40 (+200% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
| 80 (+400% Cutoff) | 15 | 5 | 0 | 5 | 0 | 5 | 0 | 15/15 |
Table 1. Chemtrue® hCG Pregnancy Urine Midstream Test:
CONCLUSION: The results confirmed the claimed cutoff (sensitivity) levels for the Chemtrue hCG Pregnancy Urine Midstream Test of 20 mIU/mL. Also the results demonstrated that the consistency between lots.
2. Reproducibility (Precision) Study:
a. Precision/Reproducibility: The study was conducted in three (3) POL sites by a total of nine (9) operators and three (3) operators for each site with three (3) lots over five (5) nonconsecutive days. The blind coded controls were used with hCG spiked at the concentrations of 0, 10, 15, 20, 25, 30, 35, and 40 mIU/mL in urine. The controls were calibrated against WHO 5th IS (07/364). Every device was tested by using simulated midstream method and interpreted by the same operator each day. The reproducibility among the sites is summarized in Table 2 below:
3
| Sites | TOTAL | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Spec. | + | - | + | - | + | - | + | - | |
| hCG | |||||||||
| concentration | |||||||||
| (mIU/mL) | 0 | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 |
| 10 (-50%cutoff) | 0 | 9 | 0 | 9 | 0 | 9 | 0 | 27 | |
| 15 (-25%cutoff) | 1 | 8 | 1 | 8 | 1 | 8 | 3 | 24 | |
| 20 (Cut-off) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 25 (+25%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 30 (+50%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 | |
| 35 (+75%cutoff) | 9 | 0 | 9 | 0 | 9 | 0 | 27 | 0 |
Table 2. Reproducibility among three (3) clinical sites
CONCLUSION: The results demonstrate a consistent functional performance of the Chemtrue hCG Pregnancy Urine Midstream Test between the sites.
-
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test. -
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Chemtrue® hCG Pregnancy Urine Midstream Test is calibrated against reference material traceable to WHO International Standard 5th edition.
A shelf-life stability test of the devices was performed in real-time and accelerated temperatures at 40°C and 60°C, respectively. The results support that the devices were stable for 24 months when stored at 25±2ºC in the sealed foil pouch. -
d. Detection limit:
Refer to the cutoff characteristics/sensitivity and precision data. The detection limit was demonstrated to be 20 mIU/mL. -
e. Analytical specificity:
The cross-reactivity study was carried out with three (3) lots of Chemtrue® hCG Pregnancy Urine Midstream Test by adding known amount of structurally-related potential cross reactants of human luteinizing hormone (hLH), human follicle stimulating hormone (hFSH) and human thyroid stimulating hormone (hTSH) to the hCG negative (5mIU/mL) and positive (50 mlU/mL) samples in urine, respectively. The results demonstrate that there is no interference at 1000 IU/L FSH, 500IU/L LH, or 1000 IU/L TSH for both negative and positive urine samples.
To evaluate the potential for interference with certain exogenous compounds, each compound was prepared by diluting stock interferent material to the desired concentration. Pooled urine samples containing 0 and 20 mIU/mL hCG were spiked with the interferents to obtain the desired test concentration. The samples were tested using simulated midstream method with three (3) different lots of Chemtrue® hCG Pregnancy Urine Midstream Test. No interference was observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples:
4
Table 3.
| Substance | Concentration |
|---|---|
| Acetylsalicylate Acid | 20 mg/dL |
| Albumin (Human) | 2000 mg/dL |
| Ascorbic Acid | 20 mg/dL |
| Atropine | 20 mg/dL |
| Bilirubin | 2 mg/dL |
| Caffeine | 20 mg/dL |
| Cannabinol | 10 mg/dL |
| Ephedrine | 20 mg/dL |
| Gentisic Acid | 20 mg/dL |
| Glucose | 2000 mg/dL |
| Hemoglobin | 250 mg/dL |
| Ibuprofen | 40 mg/dL |
| Methadone | 10 mg/dL |
| Morphine | 6 ug/dL |
| Phenylpropanolamine | 20 mg/dL |
| Salicylic acid | 20 mg/dL |
| Uric Acid | 20 mg/dL |
To ensure that the Chemtrue® hCG Pregnancy Urine Midstream Test does not interfere with B-core hCG fragment, five (5) replicates from three lots were tested with the spiked B-core hCG fragment (Source: WHO reference reagent 99/708) at the concentration of 125,000, 250,000, 500,000 and 1,000,000 pmol/mL in to 5 and 50 mlU/mL hCG of the urine controls, respectively. The results demonstrate that ß-core hCG fragment up to 1,000,000 pmol/mL does not interfere with Chemtrue® hCG Pregnancy Midstream Test.
The pH effect was evaluated by testing spiked hCG concentrations of 0 and 20 mlU/mL at pH 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0. Duplicate tests were performed at each level for each test format. The results indicate that over the pH range from 2.0 to 9.0, no interference was observed with the Chemtrue® hCG Pregnancy Urine Midstream Test.
The specific gravity (SG) effect was evaluated by testing the diluted urine at the SG of 1.003, 1.005, 1.010, 1.020 and 1.030 with spiked hCG concentrations at 0 and 20 mIU/mL, respectively. Duplicated tests were performed at each level. The results demonstrate that no interference was observed with the Chemtrue® hCG test over the SG range from 1.003 to 1.030.
High dose /hook effect was evaluated on three (3) lots with spiked non-pregnant urine pool at hCG concentrations of 50, 100, 200, 300 and 500 IU/mL. Five (5) replicates were tested each lot at each hCG concentration using simulated midstream test method. The results demonstrate that no hook effect was observed with the hCG concentrations up to 500 IU/mL in urine.
- f. Assay Cutoff:
5
The cut-off for a positive test for Chemtrue® hCG Pregnancy Urine Midstream Test is 20 mIU/mL.
-
- Method Comparison Study Data Summary: Urine samples were collected from 100 women per hospital presenting at three (3) hospitals to test for pregnancy. Approximately half of the women who were suspected to be pregnant. Fifty-five (55) participants were either in the early first trimester of pregnancy or later in the first trimester. Samples were randomly collected at various times throughout the day. Age range was from 22 to 39 years. All subjects performed self-test and collected samples for tests by healthcare professionals (HCPs) with the proposed Chemtrue® hCG Pregnancy Urine Midstream Test and the predicate device. Each specimen was evenly split into three aliquots with a unique set of blind codes. The results are summarized in tables below:
| Predicate Device - OSOM® Card hCG-Urine Test | Total | |||
|---|---|---|---|---|
| Positive | Negative | Agreement % | ||
| Chemtrue® hCG Midstream | ||||
| Tested by Professionals | ||||
| N=300 | Positive | 150 | 0 | 100% |
| Negative | 0 | 150 | ||
| Total | 150 | 150 |
Table 4. Comparison Chemtrue® hCG Midstream Test with predicate device by professionals
CONCLUSION: The agreement of Chemtrue® hCG Pregnancy Urine Midstream Test with the predicate device is 100%.
-
- OTC lay-user Study: To confirm the cut-off with the intended use population and evaluate the suitability of the Chemtrue® hCG Pregancy Urine Midstream Test to be used by the home use consumers (lay persons), natural and spiked urine samples were tested by the lay persons and the results were compared with the HCPs' results.
Negative urine sample pools were spiked with 10. 15 and 25 mlU/mL hCG to create samples with concentrations near the cut-off concentration (20 mIU/mL). Each concentration sample pool was split into 100 individual vials. All aliquots were blindly labeled by the Clinical Research Coordinator.
- OTC lay-user Study: To confirm the cut-off with the intended use population and evaluate the suitability of the Chemtrue® hCG Pregancy Urine Midstream Test to be used by the home use consumers (lay persons), natural and spiked urine samples were tested by the lay persons and the results were compared with the HCPs' results.
One hundred (100) women with diversified education backgrounds and ages ranging from 22-39 years participated in the lay user study. The study was performed at three (3) clinical sites. These 100 female participants suspecting pregnancy tested their own urine and one masked sample using midstream method per the English package insert as guide to perform the test. Aliquots of the participants' urine and spiked urine were tested by HCPs using dip method. The results are summarized results in Tables 5 and 6 below:
Table 5. Compare the OTC Lay-user testing using Midstream method with HCPs in Dip method
| Dip Method by HCPs | Total Agreement % | |||
|---|---|---|---|---|
| Positive | Negative | |||
| Midstream Method | ||||
| by OTC lay-user | ||||
| N=100 | Positive | 55 | 0 | |
| Negative | 0 | 45 | 100% | |
| Total | 55 | 45 |
6
Table 6. Cut-off testing results by lay-users using simulated midstream method vs HCPs using dip method
| Number of positive results to the total number of tested samples | ||
|---|---|---|
| Masked spiked hCG | ||
| Concentrations | Tested by Lay-users using simulated | |
| midstream method | Tested by HCPs using dip | |
| method | ||
| 10 mIU/mL (-50% of the cutoff) | 0/33 | 0/33 |
| 15 mIU/mL (-25% of the cutoff) | 2/34 | 1/34 |
| 25 mIU/mL (+25% of the cutoff) | 33/33 | 33/33 |
DISCUSSION: The results further confirm the cut-off of the Chemtrue® hCG Pregnancy Urine Midstream Test. The results demonstrate the equivalency of the Midstream testing method and dip method and the suitability of the Chemtrue® hCG Pregnancy Urine Midstream Test to be used by the home use consumers (lay persons), in comparison with healthcare professionals (HCPs). The results also demonstrate the 100% agreement between OTC layusers and healthcare professionals.
- Each patient was given an English questionnaire to assess the readability of the labeling. A Flesch-Kincaid reading analysis was performed on all package inserts and the score revealed a reading Flesch-Kincaid Grade Level 7. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have difficulty to understanding the labeling and interpreting the results.
G. Standard/Guidance Document Referenced (if applicable):
- · Guidance for industry and FDA reviewers/staff: Guidance for over-the-counter (OTC) Human chorionic gonadotropin (hCG) 510(k)s. Documents issued on: July 22, 2000.
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 features a stylized eagle with three wavy lines extending from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
July 26, 2013
Chemtron Biotech, Inc. C/O Jane Zhang 8370 Juniper Creek Lanc SAN DIEGO CA 92126
Re: K131931
Trade/Device Name: Chemtrue hCG Pregnancy Urine Midstream Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX Dated: June 26, 2013 Received: June 27, 2013
Dear Ms. Zhang:
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 prodicate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CcntersOfTices/CDRH/CDRHOffices/ucm115809.htm for
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the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincercly yours,
Courtney H. Lias, Ph.D.
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131931
Device Name: Chemtrue® hCG Pregnancy Urine Midstream Test
Indications For Use:
The Chemtrue® hCG Pregnancy Urine Midstream Urine Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in midstream format. The test is designed to aid early detection of pregnancy by home users. The device is intended for Over-The-Counter (OTC) Use.
Prescription Use______________________________________________________________________________________________________________________________________________________________
And / Or
Over the Counter Use X
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.07.26 07:38:36 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131931
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