(159 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the Preview Digital Pregnancy Test, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for qualitative pregnancy tests typically revolve around their sensitivity and specificity (accuracy in detecting or ruling out pregnancy). While explicit "acceptance criteria" are not listed as a separate section with numerical targets, the document demonstrates the device's performance against expected standards for sensitivity (25 mIU/mL) and specificity (100%).
| Acceptance Criteria (Implied/Demonstrated Standard) | Reported Device Performance (Preview Digital Pregnancy Test) |
|---|---|
| Analytical Sensitivity: 100% detection at 25 mIU/mL hCG | 100% detection at 25 mIU/mL hCG (across 3 lots for both dip and in-stream methods) |
| Analytical Specificity: 0% false positives in non-pregnant individuals | 100% specificity (0% false positive rate) in 300 non-pregnant urine samples |
| Hook Effect: No false negatives at high hCG concentrations | No hook effect observed up to 500,000 mIU/mL hCG |
| Interference: No interference from common substances, pH, or specific gravity | No interference observed from 30 listed substances, pH 4-9, and specific gravity 1.000-1.035 |
| Precision: Consistent results across lots, operators, and days at various hCG concentrations | Consistent results demonstrated across 3 lots, 3 lab technicians, and 5 days for various hCG levels and negative samples. |
| Clinical Performance (Positive Conformity): High agreement with predicate device for positive samples | 100% positive conformity with predicate device (both dip and in-stream) |
| Clinical Performance (Negative Conformity): High agreement with predicate device for negative samples | 100% negative conformity with predicate device (both dip and in-stream) |
| Lay User Performance (Positive Conformity): High agreement with professional results for positive samples | 100% positive conformity with professional results (first lay study) |
| Lay User Performance (Negative Conformity): High agreement with professional results for negative samples | 100% negative conformity with professional results (first lay study) |
| Lay User Performance (Correct Results): High percentage of correct results for spiked samples at specified concentrations | 100% correct results for 5 mIU/mL and 25 mIU/mL spiked samples (second lay study) |
Study Information
2. Sample sizes used for the test set and the data provenance:
- Analytical Sensitivity:
- 30 samples per hCG concentration level (0, 5, 12.5, 15, 18.75, 25, 50, 100 mIU/mL) for each of 3 lots (total 30 x 8 x 3 = 720 tests for dip and 720 tests for in-stream).
- Provenance: Samples were prepared "in negative urine pool" and "calibrated against the WHO 4th IS for hCG", suggesting laboratory-prepared (synthetic/spiked) samples.
- Analytical Specificity:
- 300 urine samples (100 each from pre-menopausal, peri-menopausal, and post-menopausal non-pregnant females).
- Provenance: Retrospective, collected from normal, non-pregnant females. Country of origin not specified, but the submitter is from China.
- Hook Effect:
- Samples spiked with hCG concentrations from 6,250 to 500,000 mIU/mL. Specific number of samples per concentration not given, but it implies a range of samples tested across these concentrations.
- Provenance: Laboratory-prepared (spiked) negative urine samples.
- Interfering Substance:
- Urine samples containing 0, 5, 25, and 100 mIU/mL hCG spiked with each interfering substance. Specific number of samples per substance not given.
- Provenance: Laboratory-prepared (spiked) urine samples.
- Precision:
- 50 replicates per hCG concentration (0, 5, 12.5, 15, 18.75, 25, 50, 100, 1000 mIU/mL) for each of 3 lots (total 50 x 9 x 3 = 1350 tests for dip and 1350 tests for in-stream).
- Provenance: Laboratory-prepared (spiked) negative human urine samples.
- Method Comparison Study:
- 300 urine samples collected from women presenting to test for pregnancy (approximately half suspected pregnant).
- Provenance: Prospective collection from unknown locations (likely the submitter's country or chosen clinical sites).
- Lay Person Study (First):
- 200 women for self-testing.
- Provenance: Prospective, collected from women. "Varying educational and occupational backgrounds from three sites were chosen". Country of origin not specified.
- Lay Person Study (Second):
- 200 women for self-testing using spiked samples (100 subjects for 5 mIU/mL hCG and 100 for 25 mIU/mL hCG).
- Provenance: Laboratory-prepared (spiked) negative urine sample pools. "Each testing site had a study administrator to observe or monitor the studies". Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Analytical Sensitivity, Specificity, Hook Effect, Interfering Substances, Precision: The ground truth was established by the known concentrations of hCG in the reference standards or spiked samples, traceable to the WHO 4th IS for hCG. This does not involve human experts for ground truth establishment.
- Method Comparison Study: The ground truth for the 300 clinical samples was established by the results of the "predicate device". There's no mention of independent expert adjudication for these samples.
- Lay Person Study (First): The ground truth was established by "professional testing" of the samples. The number and qualifications of these professionals are not specified.
- Lay Person Study (Second): The ground truth was established by the known spiked concentration of hCG (0, 5 mIU/mL, 25 mIU/mL).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None specified for any part of the study in terms of expert adjudication.
- For the analytical studies, ground truth was by reference standard/known concentration.
- For the method comparison, the predicate device served as the reference.
- For the first lay person study, "professional testing" served as reference, but the method for their consensus or adjudication is not detailed.
- For the second lay person study, ground truth was by known spike concentration.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was performed. This device is a standalone digital pregnancy test, not an AI-assisted interpretation system for human readers. Its output is a direct digital result (effectively an "AI" in the sense of an automated algorithm, but without a human-in-the-loop component for interpretation that would be improved by AI assistance).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The device itself provides a digital readout (LCD screen) after interpreting the immunochromatographic assay. The "algorithm" is inherent in the device's mechanism to detect and display the presence or absence of hCG, replacing visual interpretation of lines by a human. The lay person study confirms its standalone performance with non-expert users.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Known Reference Standards/Spiked Samples: For analytical sensitivity, Hook effect, interfering substances, and precision studies. These are traceable to the WHO 4th International Standard for hCG.
- Predicate Device Results: For the method comparison study.
- Professional Testing Results: For the first lay person study. (Specifics not provided for how "professional testing" itself established ground truth).
- Known Spiked Sample Concentrations: For the second lay person study.
8. The sample size for the training set:
- Not applicable / Not specified. This device is an immunoassay, not a machine learning model that requires a "training set" in the conventional sense of AI development. Its performance is based on the chemical and optical design of the lateral flow assay and the internal programming to interpret the signal, which is not typically "trained" on data in the same way an AI algorithm is.
9. How the ground truth for the training set was established:
- Not applicable. As explained above, there's no traditional "training set" for this type of IVD device. The design and calibration are based on established immunochemical principles and reference materials.
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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
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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 ShiaLSI International Inc.504 East Diamond Ave., Suite FGaithersburg, MD 20878Telephone: 240-505-7880Fax: 301-916-6213Email: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 ofcolored 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:
| hCGconcentration | 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
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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® DigitalPregnancy Test | 83 | 0 |
| 0 | 72 |
Summary dip testing results
Summary in-stream testing results
| (In-stream Testing) | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| Preview® DigitalPregnancy 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
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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.
§ 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.