(92 days)
This test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This test is for Over-The-Counter use only.
A qualitative visual immuno-chromatographic assay, single step, single use stick test
The provided text details the 510(K) summary for the Instant-View™ Pregnancy Urine Mid-Stream Test, manufactured by Alfa Scientific Designs, Inc. This diagnostic device is a qualitative visual immuno-chromatographic assay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy, intended for Over-The-Counter (OTC) use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Correlation with predicate device) | 100% correlation with the predicate device (OSOM Pregnancy Urine Test) |
| Agreement between consumers and professionals/actual patient status | 100% agreement between results obtained from consumers and those obtained from professionals/actual patient status. No discrepancy found between subject device and predicate device results as interpreted by professionals. |
| Consumer usability (simplicity, speed, convenience, accuracy) | Over 99% of consumers found the device simple, fast, convenient and accurate. |
| Repeatability (intra- and inter-assay precision) | 100% agreement with expected results from three POL (Physician Office Laboratory) sites, indicating high repeatability. |
| Safety and Effectiveness | Concluded to be as safe, as effective, and to perform as well as the legally marketed OTC device (predicate device). |
2. Sample Size and Data Provenance for the Test Set
- Consumers for User Study: The exact sample size for the consumer study is not explicitly stated, but the text mentions "consumers" in the plural, suggesting more than one.
- Professionals for User Study: The exact sample size for professionals is not explicitly stated.
- POL Sites for Repeatability Study: Three POL sites were used in the evaluation.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the submission is to the US FDA, it is highly likely the studies were conducted in the US. The studies appear to be prospective, specifically designed to gather data for the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth - Test Set
- Consumer Study: The "actual patient status" and those provided by "professionals" served as the ground truth. The qualifications of these "professionals" are not specified, but they are likely clinical laboratory professionals or physicians involved in pregnancy diagnosis.
- Correlation Study: The results from the predicate device (OSOM Pregnancy Urine Test) served as the ground truth.
- POL Evaluations: The "expected results" were used as ground truth. The expertise involved in defining these "expected results" is not explicitly detailed but would typically involve laboratory standards and potentially qualified lab personnel.
4. Adjudication Method for the Test Set
- Consumer Study: The text mentions "100% agreed with that obtained from the professionals and the actual patient status. No discrepancy was found." This suggests a direct comparison method, where the consumer's self-interpretation was checked against professional interpretation and/or the actual clinical status.
- Correlation Study: "Accuracy by correlation of the results from the Instant-View™ Pregnancy Urine Mid-Stream Test and the predicate device was 100%." This implies a direct comparison for agreement, where the predicate device's result was the reference.
- POL Evaluations: "Evaluation results from three POL sides agreed 100% with the results expected." This indicates consensus among the POL sites or agreement with a predefined standard.
No explicit adjudication method like "2+1" or "3+1" is mentioned, rather direct comparison and high agreement were the reported outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study is explicitly described within the provided text. The studies focus on standalone device performance, correlation with a predicate, and consumer usability without comparing human readers' performance with and without AI assistance. The device itself is a qualitative visual test, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone (Algorithm Only) Performance
- Yes, standalone performance was done. The "Discussion and Conclusion" sections heavily emphasize the device's independent performance by correlating its results with the predicate device and establishing its own accuracy and repeatability. The "consumer studies" also implicitly evaluate the standalone performance as interpreted by consumers. The device is a "single step, single use stick test," meaning its performance is inherently standalone.
7. Type of Ground Truth Used
- Expert Consensus/Clinical Standard: For the consumer study, the ground truth was based on "professionals and the actual patient status," which implies a clinical diagnosis or gold standard from trained personnel.
- Predicate Device Results: For the correlation study, the results of the legally marketed predicate device (OSOM Pregnancy Urine Test) served as the ground truth.
- Expected Results/Laboratory Standards: For the POL evaluations, the ground truth was "results expected," which would be based on established laboratory testing standards for hCG.
8. Sample Size for the Training Set
- The document does not explicitly mention a training set in the context of machine learning or algorithm development. The device is a lateral flow immunoassay, not a software-based AI algorithm that typically requires a training set. The studies described are validation studies for the finished product.
9. How the Ground Truth for the Training Set was Established
- As there is no explicit mention of a training set or AI algorithm development, this point is not applicable based on the provided text. The ground truth establishment described pertains to the validation (test) phase.
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Image /page/0/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo is a stylized "alpha" symbol. Above the logo is the date 2/16/99.
Medical Diagnostic Devices. Contract R&D. OEM 11494 Sorrento Valley Rd, Suite F & M San Diego, CA 92121 Tel: (619) 350-9798 Fax: (619) 350-9709 E-mail: asdi@worldnet.att.net
510(K) Summary (K984075)
| Submitter | Name and address: Alfa Scientific Designs, Inc.11494 Sorrento Valley Rd, Suite MSan Diego, CA 92121 |
|---|---|
| 619-350-9798 (Tel)619-350-9709 (Fax) | |
| Contact Person: Naishu Wang, MD, Ph.D. | |
| Date Prepared: 1/8/99 | |
| Device Name | Trade Name: Instant-ViewTM Pregnancy Urine Mid-Stream Test |
| Common Name: Human Chorionic Gonadotropin (hCG) Test | |
| Classification name: 21CFR section 862.1155, Class II.A Qualitative Human ChorionicGonadotropin (hCG) test system. | |
| Predicate device | The Instant-ViewTM Pregnancy Urine Mid-Stream Test issubstantially equivalent to OSOM Pregnancy Urine Test made byWyntek Diagnostic, Inc., 510K#: K954178. |
| Device description | A qualitative visual immuno-chromatographic assay, single step,single use stick test |
| Intended use | The Instant-ViewTM Pregnancy Urine Mid-Stream Test is a homepregnancy urine test for use as an aid in the diagnosis of earlypregnancy. |
| Continued on next page | |
| Summary of thesimilarities to thepredicate device | • The intended use and performance characteristics:Both devices are OTC devices intended to use for an earlydetection of hCG in human urine.• Technological characteristics:Both devices are one step, qualitative, lateral flow, visualimmuno-chromatographic test in a sandwich complex format ofanti-hCG antibody /hCG/ anti-hCG antibody.• Interpretation of results:The presence of C line serves as an internal quality control, andthe presence of the T line indicates a positive result. |
| Discussion andConclusion | • The consumer studies demonstrated that the results obtained fromconsumers were 100% agreed with that obtained from theprofessionals and the actual patient status. No discrepancy wasfound between the results obtained by the professionals from thesubject device and the predicate device.Over 99% of the consumers found the Instant-ViewTM PregnancyUrine Mid-Stream Test is simple, fast, convenient and accurate. |
| • The comparison studies demonstrated that the accuracy bycorrelation of the results from the Instant-ViewTM PregnancyUrine Mid-Stream Test and the predicate device was 100%. Itindicates that the Instant-ViewTM Pregnancy Urine Mid-StreamTest is substantially equivalent to the predicate device. | |
| • The evaluation results from three POL sides agreed 100% withthe results expected, indicating that the testing results are highlyrepeatable. | |
| • Based on the results of the correlation study, consumer study andPOL evaluations, we may conclude that the Instant-ViewTMPregnancy Urine Mid-Stream Test has excellent intra- and inter-assay precision. It is as safe, as effective, and performs as wellas the legally marketed OTC device. Therefore, this device issuitable for use as an OTC pregnancy test. |
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Image /page/2/Picture/1 description: The image is the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, with three lines forming the body and head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 1999
Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road, Suite F&M San Diego, CA 92121
Re: K984075
Trade Name: Instant-View Pregnancy Urine Mid-Stream Test Regulatory Class: II Product Code: 75 LCX Dated: January 8, 1999 Received: January 12, 1999
Dear Dr. Wang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) NUMBER (IF KNOWN): K 984075 DEVICE NAME : Instant-View™ Pregnancy Urine Mid-Stream Test INDICATIONS FOR USE:
This test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
This test is for Over-The-Counter use only.
ean Looxh
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984075
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
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§ 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.