(92 days)
Not Found
No
The device description and performance studies indicate a simple, visual immunoassay with no mention of AI/ML technology or complex data processing.
No
Explanation: This device is for the detection of pregnancy (diagnostic), not for the treatment or prevention of a medical condition (therapeutic).
Yes
The device is described as "a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy," which directly indicates it is used to identify a medical condition (pregnancy).
No
The device description clearly states it is a "qualitative visual immuno-chromatographic assay, single step, single use stick test," which is a physical hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to gain information about a physiological state (pregnancy).
- Device Description: It's described as a "qualitative visual immuno-chromatographic assay." Immunoassays are a common type of IVD test.
- Sample Type: It uses urine, which is a biological specimen.
The fact that it's for Over-The-Counter use and a home pregnancy test doesn't change its classification as an IVD. IVDs can be used in various settings, including at home.
N/A
Intended Use / Indications for Use
The Instant-ViewTM Pregnancy Urine Mid-Stream Test is a home pregnancy urine test for use as an aid in the diagnosis of early pregnancy.
This test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
75 LCX
Device Description
A qualitative visual immuno-chromatographic assay, single step, single use stick test
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
home; Over-The-Counter use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The consumer studies demonstrated that the results obtained from consumers were 100% agreed with that obtained from the professionals and the actual patient status. No discrepancy was found between the results obtained by the professionals from the subject device and the predicate device. Over 99% of the consumers found the Instant-ViewTM Pregnancy Urine Mid-Stream Test is simple, fast, convenient and accurate.
The comparison studies demonstrated that the accuracy by correlation of the results from the Instant-ViewTM Pregnancy Urine Mid-Stream Test and the predicate device was 100%. It indicates that the Instant-ViewTM Pregnancy Urine Mid-Stream Test is substantially equivalent to the predicate device.
The evaluation results from three POL sides agreed 100% with the results expected, indicating that the testing results are highly repeatable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.
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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 M
San 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 Chorionic
Gonadotropin (hCG) test system. |
| Predicate device | The Instant-ViewTM Pregnancy Urine Mid-Stream Test is
substantially equivalent to OSOM Pregnancy Urine Test made by
Wyntek 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 home
pregnancy urine test for use as an aid in the diagnosis of early
pregnancy. |
| | Continued on next page |
| Summary of the
similarities to the
predicate device | • The intended use and performance characteristics:
Both devices are OTC devices intended to use for an early
detection of hCG in human urine.
• Technological characteristics:
Both devices are one step, qualitative, lateral flow, visual
immuno-chromatographic test in a sandwich complex format of
anti-hCG antibody /hCG/ anti-hCG antibody.
• Interpretation of results:
The presence of C line serves as an internal quality control, and
the presence of the T line indicates a positive result. |
| Discussion and
Conclusion | • The consumer studies demonstrated that the results obtained from
consumers were 100% agreed with that obtained from the
professionals and the actual patient status. No discrepancy was
found between the results obtained by the professionals from the
subject device and the predicate device.
Over 99% of the consumers found the Instant-ViewTM Pregnancy
Urine Mid-Stream Test is simple, fast, convenient and accurate. |
| | • The comparison studies demonstrated that the accuracy by
correlation of the results from the Instant-ViewTM Pregnancy
Urine Mid-Stream Test and the predicate device was 100%. It
indicates that the Instant-ViewTM Pregnancy Urine Mid-Stream
Test is substantially equivalent to the predicate device. |
| | • The evaluation results from three POL sides agreed 100% with
the results expected, indicating that the testing results are highly
repeatable. |
| | • Based on the results of the correlation study, consumer study and
POL evaluations, we may conclude that the Instant-ViewTM
Pregnancy Urine Mid-Stream Test has excellent intra- and inter-
assay precision. It is as safe, as effective, and performs as well
as the legally marketed OTC device. Therefore, this device is
suitable 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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