The Instant-View TM Pregnancy Combo Test is designed for qualitative detection of the human chorionic gonadotropin (hCG) in human urine and serum. The test is for use as an aid in the diagnosis of early pregnancy.
The Instant-View Pregnancy Combo Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for laboratory and professional use only.

Device Description

A single step, visually read, qualitative chromatographic immunoassay, single use cassette test

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Instant-View™ Pregnancy Combo Test, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (like minimum sensitivity or specificity targets). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The primary acceptance criterion appears to be achieving 100% agreement with the predicate device in terms of results.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to legally marketed devices via 100% correlation of results	Accuracy: 100% correlation with QuikpacII-One Step HCG Combo Test (predicate device). Agreement with expected results: 100% agreement in clinical lab and physician's offices studies.
Intended use: Early detection of hCG in human urine and serum at levels close to or greater than 25 mIU/ml (calibrated against WHO 3rd IS 75/537)	Performance meets this intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document states "The evaluation results from clinical lab and three physician's offices." It does not provide the specific sample size for the test set (number of urine/serum samples or individual subjects).

Data Provenance: The study was conducted in a "clinical lab and three physician's offices." It doesn't specify a country of origin but implies a US context given the FDA submission. The context of a 510(k) submission generally implies prospective studies for the device seeking approval, but the exact nature (retrospective/prospective) of the sample collection for this specific study is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states, "evaluation results from clinical lab and three physician's offices conducted by the persons with diverse educational backgrounds and working experience agreed 100% with the results expected."

Number of Experts: Not explicitly stated. It refers to "persons" at the clinical lab and physician's offices, implying multiple individuals.
Qualifications of Experts: Described as "persons with diverse educational backgrounds and working experience." Specific professional qualifications (e.g., radiologist, medical technologist) and years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that the "results agreed 100% with the results expected," suggesting direct comparison to a known or established 'true' result for each sample, rather than a concensus process among multiple readers for the test device itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly done. The study's focus was on demonstrating substantial equivalence to a predicate device by comparing the new device's results to the predicate's results and "expected results." There is no mention of human readers improving with or without AI assistance, as this is a qualitative immunoassay device, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire evaluation described is of the "Instant-View™ Pregnancy Combo Test" itself. Its performance was assessed independently by comparing its results to a predicate device and "expected results" in a clinical setting.
- Accuracy: It showed 100% correlation with the predicate device (QuikpacII-One Step HCG Combo Test) and 100% agreement with expected results.

7. Type of Ground Truth Used

The ground truth appears to be established through two primary methods:

Predicate Device Comparison: The results of the Instant-View™ Pregnancy Combo Test were compared 100% to those of the "QuikpacII-One Step HCG Combo Test" (the predicate device, K945951), which is assumed to provide the ground truth for comparison.
"Expected Results": The evaluation also agreed 100% with "results expected." This implies that for some samples, the true hCG status (positive/negative) was known beforehand, possibly through reference methods or clinical diagnosis, serving as a form of ground truth.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a qualitative immunoassay, not an AI/machine learning device that typically requires a distinct training set. The descriptions relate to the evaluation of the final product.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the establishment of ground truth for such a set is not applicable or described in this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the date 2/16/99 at the top left corner. Below the date is the logo for Alfa Scientific Designs, Inc. The logo is a stylized "alpha" symbol. The text "ALFA SCIENTIFIC DESIGNS, INC." is to the right of the logo.

Medical Diaqnostic Devices. Contract R&D. OEM 11494 Sorrento Valley Rd, Suite F & M San Diego, CA 92121 Tel: (619) 350-9798 Fax: (619) 350-9709

Fax: (19/35-975E-mail: asdi@worldnet.att.net 510(K) Summary (K984077)

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: 12/30/98

Device Name

Trade Name: Instant-View™ Pregnancy Combo 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-View TM Pregnancy Combo Test is substantially equivalent to other legally marketed devices for the similar intended use. The device used for comparison study is the QuikpacII-One Step HCG Combo Test made by Syntron Bioresearch, Inc. The 510(K)# is K945951.

Device description

A single step, visually read, qualitative chromatographic immunoassay, single use cassette test

Intended use

Continued on next page

510(K) Summary

{1}------------------------------------------------

Summary of thesimilarities to thepredicate device	• The intended use and performance characteristics:Both devices are intended to use for an early detection of hCGin human urine and serum at the level close to or greater than 25mIU/ml (calibrated against the WHO 3rd IS 75/537).
	• Technological characteristics:Both devices are one step, qualitative, visual lateral flowimmuno-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 accuracy by correlation of the results from the Instant-View ™ Pregnancy Combo Test and the legally marketed testcompared is 100%, indicating that the Instant-View ™Pregnancy Combo Test is substantially equivalent to thisexisting legally marketed product.
	• The evaluation results from clinical lab and three physician'soffices conducted by the persons with diverse educationalbackgrounds and working experience agreed 100% with theresults expected.
	• Based on the results of the correlation and POL studies, we mayconclude that the Instant-View ™ Pregnancy Combo Test is assafe, as effective, and performs as well as the legally marketeddevice. Therefore, this test is suitable for use by health careprofessionals with diverse educational backgrounds and workexperience.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a triple-stranded helix design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

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: K984077

Trade Name: Instant-View Pregnancy Combo Test Regulatory Class: II Product Code: 75 JHI Dated: January 6, 1999 Received: January 11, 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 (QS) 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.

{3}------------------------------------------------

Page 2

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 Sutman

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

{4}------------------------------------------------

Page 14 of 14

Labels	Values
510(k) Number (if known)	K984077
Device Name	Instant-View pregnancy Combo Test

Indications For Use:

The Instant-View Pregnancy Combo Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy.

This test is for laboratory and professional use only.

in 66 (Division Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.