(159 days)
Not Found
No
The summary describes a standard digital pregnancy test that detects hCG levels. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on analytical and clinical accuracy based on chemical detection.
No
Explanation: This device is for diagnostic purposes, specifically for detecting pregnancy. It does not provide treatment or act on the body to cure or prevent a disease.
Yes
The device qualitatively detects human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, which is a diagnostic purpose.
No
The device description explicitly states it consists of a "single test strip encased in plastic device housing, with an absorbent tip," indicating it is a physical hardware device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to provide diagnostic information.
- Device Description: The device is designed to test urine samples.
- Performance Studies: The performance studies involve testing urine samples to evaluate the device's ability to detect hCG.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Preview® Digital Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
Preview® Digital Pregnancy Test is designed to be tested in dip and midstream modes. Preview® Digital Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The device is in a ready-to-use format and no longer requires assembly before use.
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 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)
The device's performance was evaluated through analytical performance tests (sensitivity, hook effect, traceability, stability, specificity, cross-reactivity, interfering substances, and precision), a method comparison study with a predicate device, and a lay person study.
Analytical Performance:
- Sensitivity: Determined to be 25 mIU/mL. Urine standards (0-100 mIU/mL hCG) were tested by nine operators with three lots.
- Hook Effect: No hook effect observed at hCG concentrations ranging from 6,250 to 500,000 mIU/mL.
- Specificity and cross-reactivity: 300 urine samples from normal, nonpregnant females across different age groups (18-40, 41-55, >55 years old, 100 people per group) were tested. Specificity was 100%, and false positive rate was 0%. Cross-reactivity with LH, FSH, TSH, and hCG ß-core fragment was evaluated with no interference observed.
- Interfering substance: Various exogenous compounds were spiked into urine samples (0, 5, 25, 100 mIU/mL hCG). No interferences observed from listed substances, changes in pH (4-9), or specific gravity (1.000-1.035).
- Precision: Human urine samples spiked with varying hCG concentrations were measured in 10 replicates per day using 3 different lots for 5 consecutive days by three different lab technicians.
Method comparison study:
- Type: Method comparison with predicate device.
- Sample size: 300 urine samples from women presenting for pregnancy testing (approximately half suspected pregnant in early stages).
- Key results: Samples were tested by three health professionals at each of 3 POC sites (total 9 operators) with both the proposed and predicate devices.
- Dip Testing: 83 positive for both, 72 negative for both.
- In-stream Testing: 76 positive for both, 69 negative for both.
- Conclusion: The average positive conformity rate of Digital Pregnancy Test is 100%. The average negative conformity rate of Digital Pregnancy Test is 100%.
Lay person study:
- First study:
- Sample size: 200 women from three sites.
- Data source: Self-tested individual urine samples and samples for professional testing.
- Key results: Lay person results showed 100% positive and 100% negative conformity with professional results.
- Second study:
- Sample size: 200 women.
- Data source: Blind-labeled aliquots of negative urine spiked with 5 mIU/mL hCG (100 aliquots) and 25 mIU/mL hCG (100 aliquots). Half of the subjects tested 5 mIU/mL hCG aliquots, the other half tested 25 mIU/mL hCG aliquots.
- Key results:
- 5 mIU/mL hCG: 100% correct results (0 positive, 100 negative).
- 25 mIU/mL hCG: 100% correct results (100 positive, 0 negative).
- Additional: Questionnaire results indicated consumers found the test easy to use and understood labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 mIU/mL
Specificity: 100%
False positive rate: 0%
Positive conformity rate (compared to predicate): 100%
Negative conformity rate (compared to predicate): 100%
Lay person positive conformity: 100%
Lay person negative conformity: 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 12, 2018
Guangzhou Wondfo Biotech Co., Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K173229
Trade/Device Name: Preview Digital Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: February 8, 2018 Received: February 12, 2018
Dear Joe Shia:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see 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
1
801 and Part 809); medical device 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. K
for 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) K173229
Device Name Preview Digital Pregnancy Test
Indications for Use (Describe)
Preview Digital Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCC) in urine, as an aid in early detection of pregnancy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) K173229 SUMMARY
| 1. | Date: | February 6, 2018 |
|---|---|---|
| 2. | Submitter: | Guangzhou Wondfo Biotech Co., Ltd. |
| No.8 Lizhishan Road, Science City, | ||
| Luogang District, Guangzhou, Guangdong, P.R. | ||
| China 510663 | ||
| 3. | Contact person: | Joe Shia |
| LSI International Inc. | ||
| 504 East Diamond Ave., Suite F | ||
| Gaithersburg, MD 20878 | ||
| Telephone: 240-505-7880 | ||
| Fax: 301-916-6213 | ||
| Email:shiajl@yahoo.com | ||
| 4. | Device Name: | Preview® Digital Pregnancy Test |
| Classification: | Class II | |
| Product Code | LCX | |
| CFR | 862.1155 |
Predicate Devices: One step HCG Urine Pregnancy Test (K043443) ട്.
6. Intended Use
Preview® Digital Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
7. Device Description
Preview® Digital Pregnancy Test is designed to be tested in dip and midstream modes. Preview® Digital Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The device is in a ready-to-use format and no longer requires assembly before use.
Similarities Candidate device Predicate device Item Early detection of Early detection of Intended use pregnancy pregnancy Urine Specimen Urine Immunochromatographic Immunochromatographic Assay technical assay assay
8. Substantial Equivalence Information
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| Sensitivity | 25 mIU/mL | 25 mIU/mL |
|---|---|---|
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Device format | Midstream | Midstream |
| Differences | ||
| Item | Device | Predicate |
| Readout | Digital/LCD screen | Visual interpretation of |
| colored line(s) |
9. Standard/Guidance Document Reference (if applicable)
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s, July 22, 2000
10. Test Principle
This device operates by detecting human chorionic gonadotropin (hCG), the hormone produced during pregnancy in urine, using a lateral flow sandwich immunochromatographic assay.
11. Performance Characteristics
A. Analytical performance
a. Sensitivity
Urine standards containing intact hCG at concentrations of 0 mIU/mL, 5 mIU/mL, 12.5 mIU/mL, 15 mIU/mL, 18.75 mIU/mL, 25 mIU/mL, 50 mIU/mL, and 100 mIU/mL were prepared in negative urine pool and calibrated against the WHO 4th IS for hCG. These samples were tested by nine operators with three lots of Preview® Digital Pregnancy Test.
The results are summarized in the table below:
| hCG
| concentration | Lot I | Lot II | Lot III |
|---|---|---|---|
| 0 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 5 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 12.5 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 15 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 18.75 mIU/mL | 7% (2+/28-) | 10% (3+/27-) | 10% (3+/27-) |
| 25 mIU/mL | 100% (30+/0-) | 100% (30+/0-) | 100% (30+/0-) |
| 50 mIU/mL | 100% (30+/0-) | 100% (30+/0-) | 100% (30+/0-) |
| 100 mIU/mL | 100% (30+/0-) | 100% (30+/0-) | 100% (30+/0-) |
Summary urine results (dip method)
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| hCG | Lot I | Lot II | Lot III |
|---|---|---|---|
| concentration | |||
| 0 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 5 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 12.5 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 15 mIU/mL | 0% (0+/30-) | 0% (0+/30-) | 0% (0+/30-) |
| 18.75 mIU/mL | 10% (3+/27-) | 10% (3+/27-) | 10% (3+/27-) |
| 25 mIU/mL | 100% (30+/0-) | 100% (30+/0-) | 100% (30+/0-) |
| 50 mIU/mL | 100% (30+/0-) | 100% (30+/0-) | 100% (30+/0-) |
| 100 mIU/mL | 100% (30+/0-) | 100% (30+/0-) | 100% (30+/0-) |
Summary urine results (in-stream method)
Based on the above results, the sensitivity of Preview® Digital Pregnancy Test is demonstrated to be 25 mIU/mL.
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test.
Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (6,250, 12,500, 25,000, 50,000, 100,000, 200,000 and 500,000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 6,250 to 500,000 mIU/mL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Preview® Digital Pregnancy Test is calibrated against reference material traceable to WHO International Standard 4th edition.
A shelf-life stability test of the devices was performed in real-time and accelerated testing. The results showed that the devices were stable for 30 months when stored at 4~30°C in the sealed foil pouch.
d. Specificity and cross reactivity
To evaluate specificity, 300 urine samples were collected from normal, nonpregnant female in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old) and post-menopausal (>55 years old) groups. 100 people for each age group. Both dip and in-stream testing are evaluated. All samples were tested with three lots of Preview® Digital Pregnancy Test. The result indicates that the specificity of Preview® Digital Pregnancy Test is 100%, the false positive rate is 0% and there is no deviation between or within lots.
To evaluate cross-reactivity, negative and positive urine samples (0 mIU/mL, 5 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there
6
is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 250,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.
e. Interfering substance
To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 0, 5 mIU/mL, 25 mIU/mL and 100 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration. No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples.
| Interfering Substances | Concentration |
|---|---|
| Acetaminophen | 20 mg/dL |
| Acetylsalicylic acid | 20 mg/dL |
| Albumin | 20 mg/dL |
| Amoxicillin | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| Ascorbic acid | 20 mg/dL |
| Aspirin | 80 mg/dL |
| Atropine | 20 mg/dL |
| Benzoylecgonine | 10 mg/dL |
| B-hydroxybutyrate | 2000 mg/dL |
| Bilirubin | 2 mg/dL |
| Caffeine | 20 mg/dL |
| Cannabinol | 10 mg/dL |
| EDTA | 80 mg/dL |
| Ephedrine | 20 mg/dL |
| Ethanol | 1% |
| Folic Acid | 0.03 mg/dL |
| Gentisic acid | 20 mg/dL |
| Glucose | 2000 mg/dL |
| Hemoglobin | 50 mg/dL |
| Ibuprofen | 40 mg/dL |
| Ketone | 20 mg/dL |
| Phenothiazine | 20 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Pregnanediol | 1.5 mg/dL |
| Salicylic acid | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Thiophene | 20 mg/dL |
| Uric Acid | 20 mg/dL |
| Vitamin B1 | 80 mg/dL |
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To evaluate potential interference from changes in pH, urine samples containing 0 mIU/mL, 5 mIU/mL, 25 mIU/mL and 100 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.
To evaluate potential interference from changes in specific gravity, urine samples containing 0 mIU/mL, 5 mIU/mL, 25 mIU/mL and 100 mIU/mL hCG were tested at density values ranging from 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035. The results indicated that changes in specific gravity do not interfere in the results that were either positive or negative for hCG.
f. Precision
A precision study was performed using negative human urine samples spiked with varying hCG (commercially available and traceable to the 4th WHO international standard) concentrations. The spiked urine samples were measured in 10 replicates per day using 3 different lots. Tests were performed by three different lab technicians for 5 consecutive days.
| | Concentration
(mIU/mL) | 0 | 5 | 12.5 | 15 | 18.75 | 25 | 50 | 100 | 1000 |
|---------|---------------------------|--------|--------|--------|--------|--------|--------|--------|--------|------|
| Lot I | 0+/50- | 0+/50- | 0+/50- | 0+/50- | 4+/46- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot II | 0+/50- | 0+/50- | 0+/50- | 0+/50- | 5+/45- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot III | 0+/50- | 0+/50- | 0+/50- | 0+/50- | 6+/44- | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
The dip method results summary was as below:
The in-stream results summary was as below:
| Concentration
(mIU/mL)
| Lot | 0 | 5 | 12.5 | 15 | 18.75 | 25 | 50 | 100 | 1000 |
|---|---|---|---|---|---|---|---|---|---|
| Lot I | 0+/50- | 0+/50- | 0+/50- | 0+/50- | 5+/45- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot II | 0+/50- | 0+/50- | 0+/50- | 0+/50- | 5+/45- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot III | 0+/50- | 0+/50- | 0+/50- | 0+/50- | 6+/44- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
B. Method comparison study
Method comparison with predicate device
The performance of the new device was compared to the predicate test. Urine samples were collected from 300 women presenting to test for pregnancy. Approximately half of the 300 women were suspected to be pregnant and most of
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them are in the early stage of less than 5 weeks. All samples were tested by three different health professionals at each of the 3 POC sites for a total of 9 POC operators with the proposed and the predicate devices.
| (Dip Testing) | Predicate device | |
|---|---|---|
| Positive | Negative | |
| Preview® Digital | ||
| Pregnancy Test | 83 | 0 |
| 0 | 72 |
Summary dip testing results
Summary in-stream testing results
| (In-stream Testing) | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| Preview® Digital | |||
| Pregnancy Test | Positive | 76 | 0 |
| Negative | 0 | 69 |
Conclusion from the above table:
The average positive conformity rate of Digital Pregnancy Test is 100% The average negative conformity rate of Digital Pregnancy Test is 100%
C. Lay person study
First study:
200 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
Summary
| Professional | |||
|---|---|---|---|
| + | - | ||
| Lay person | + | 86 | 0 |
| - | 0 | 114 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Second study:
200 women's individual pregnancy status was self-tested. Negative urine sample pools were spiked with 5 mIU/mL hCG and 25 mIU/mL hCG. Each concentration sample pools were further aliquot into 100 individual containers. All aliquots were blind labeled by the person who prepared the samples and didn't take part in the sample testing. Half of the above subjects tested the 5 mIU/mL hCG aliquots and another half of the subjects tested the 25 mIU/mL hCG aliquots with the device according to the package insert. Each testing site had a study
9
administrator to observe or monitor the studies without providing assistance to the participants.
| Summary | ||||
|---|---|---|---|---|
| Number of samples | hCG Concentration (mIU/mL) | Lay person results | The percentage of correct results | |
| Number of Positive | Number of Negative | |||
| 100 | 5 | 0 | 100 | 100% |
| 100 | 25 | 100 | 0 | 100% |
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
12. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.