K Number

Device Name

Manufacturer

VICTORCH MEDITEK, INC.

Date Cleared

2001-12-27

(50 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card device (also The VicTorch hCG Test Card) is designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCI) assay for the early detection of pregnancy, now bolor only gated "immal test for the placental hormone, hCG, at the required cut-off level of 20 mlU hCG/ml of human urine. VicTorch hCG Test Card devices are intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCI assay of hCG, a placental hormone that may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Card devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Card devices are designed for professional use only, and provide only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

Device Description

AI/ML Overview

The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card Device is a qualitative lateral flow color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay designed for the early detection of pregnancy by identifying hCG at a cutoff level of 20 mIU/mL in human urine. It is intended for professional use only and provides preliminary analytical data, with a more specific alternative clinical method required for confirmed diagnosis.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Category	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Sensitivity	Consistent detection of 20 mIU hCG/mL or greater in human urine.	Consistently detects 20 mIU hCG/mL or greater hCG in human urine. Studies included 20% above and below 20 mIU hCG/mL and other levels from 0 to 100 mIU hCG/mL, confirming claimed detection capabilities.
Specificity	No cross-reactivity with structurally related hormones (LH, TSH, FSH) at specified concentrations.	No cross-reactivity with 500 mIU/mL of LH, 1000 µIU/mL of TSH, and 1000 mIU/mL of FSH.
Interference	No false positive or false negative results due to common OTC, prescription, abuse drugs, chemical analytes, and urine pH variations.	Common OTC, prescription, abuse drugs, chemical analytes, and normal urine pH variations did not interfere with performance, yielding no false positive or false negative results.
Specimen Collection and Storage	Maintained performance with refrigerated urine specimens.	Validated performance for hCG negative and hCG positive urine specimens refrigerated for up to three days.
Accuracy (vs. Predicate Device)	100% agreement with the predicate device (ABI's SureStep hCG Test).	Achieved 100% agreement (172/172) with ABI's SureStep hCG Test, with a 95% Confidence Interval of 99.1-99.8%.
Stability	Stable performance for at least one year.	Performance was stable for at least one year as shown in accelerated and real-time evaluations.
Substantial Equivalence	Demonstrate substantial equivalence to currently marketed predicate devices.	Support data from various studies (including 100% relative accuracy with predicate) indicate substantial equivalence.

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

Sample Size for Accuracy Study: 172 female patients.
- 91 hCG positive
- 81 hCG negative
Data Provenance: The accuracy study was conducted at an "external OBGYN clinical center." The country of origin is not explicitly stated, but given FDA submission, it's likely the US or a region with comparable clinical standards. The study appears to be prospective in nature, as it involves testing patients and comparing results.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth for the test set.
However, the accuracy study used ABI's SureStep hCG Test as the predicate device to establish the ground truth for human urine samples. Since it was an "external OBGYN clinical center," it implies that medical professionals (clinicians/laboratory personnel) were involved in collecting and evaluating samples, and determining the "true" pregnancy status based on the predicate device's results.

4. Adjudication Method for the Test Set:

The document implies a direct comparison method for the accuracy study. The VicTorch device's results were compared directly against those of the ABI's SureStep hCG Test for each of the 172 patient samples. A "complete agreement" (100%) indicates no discrepancy, thus an explicit adjudication method like 2+1 or 3+1 was not necessary as there were no disagreements between the test device and the established ground truth (predicate device).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done.
This device is a rapid in vitro diagnostic test, not an AI-powered diagnostic tool for human readers. It provides a direct, qualitative result (positive/negative) that is read visually. Therefore, the concept of human readers improving with AI assistance does not apply in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, a standalone performance study was inherently done.
The VicTorch hCG Test Card is a device where the "algorithm" (the lateral flow immunochromatographic assay itself) provides the result directly, without requiring human interpretation beyond reading a positive or negative line. The sensitivity, specificity, interference, and stability studies, as well as the accuracy study comparing it to a predicate device, all demonstrate its standalone performance.

7. The Type of Ground Truth Used:

The primary ground truth for the accuracy study was established by comparison to a legally marketed predicate device: ABI's SureStep hCG Test. This is a common practice for demonstrating substantial equivalence for new IVD devices.
For the other studies (sensitivity, specificity, interference), the ground truth was based on controlled sample preparations (e.g., specific concentrations of hCG, LH, TSH, FSH, or interfering substances).

8. The Sample Size for the Training Set:

The document describes performance evaluation studies for the final device to support its 510(k) submission, not the development or training of an algorithm in the machine learning sense. Therefore, there isn't a "training set" as understood in AI/ML contexts. The data presented are from validation/verification studies.

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

As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The development of such a lateral flow assay involves extensive R&D and optimization (analogous to training), but the "ground truth" during that phase would be based on known concentrations of analytes and clinical samples with confirmed pregnancy status, iteratively used to refine the reagent formulations and device design.

Summary

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510k Submission for VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card Device

VicTorch Meditek, Inc.

roprietary Information DEC 2 7 2001 Revision B, September 19, 2001

9. SUMMARY STATEMENT OF SAFETY AND EFFECTIVENESS

The VicTorch hCG Test Card device is a lateral flow qualitative color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay for human Chorionic Gonadotropin (hCG) on the cutoff level of 20 mlUml of human urine, for detection of early pregnancy as commonly used by professionals. Measurements obtained by the qualitative VicTorch hCG Test Cards are used to aid in the diagnosis of pregnancy. VicTorch hCG Test Card devices are classified as about II Devices, as described in Section 21 CFR 862.1155 Human Chorionic Gonadotropin (hCG) Test Systems, having product code: 91 DHA.

These VicTorch hCG Test Card devices are IVD tests designed to give rapid, visual, qualitative results and are intended for professional use only. VicTorch hCG Test Card devices are not intended for quantitative results, nor for over-the-counter sales. The VicTorch hCG Test Cards provide only preliminary analytical data. A more specific alternative clinical method must be used to obtain a confirmed analytical result.

In order to determine if the VicTorch hCG Test Card devices can function as effectively as other FDA approved and currently marketed similar hCG test devices (such as ABI's SureStep hCG Test Card devices), a number of evaluation studies were done with the VicTorch hCG Test Cards as listed herein. These studies included: (1) Sensitivity studies that includes 20% above and below 20 mlU hCG/ml cutoff concentration and other 0 to 100 mlU hCG/ml levels that indicated the VicTorch hCG Test Card can consistently detect 20 mlU hCG /ml or greater hCG in human urine as it claimed. (2) Specificity studies against other structurally related hormones such as 500 mlU/ml of LH, 1000 µlU/ml of TSH, and 1000 mlU/ml of FSH that shown that these hormones do not cross-react with the VicTorch hCG Test Card at the indicated test levels. (3) Interference studies against analytes commonly found in OTC, prescription and/or abuse drugs proved that those drugs, chemical analytes, and pH (varied within normal range for human urine) did not interfere VicTorch hCG Test Card performance, yielding no false positive or false negative results. (4) The Specimen Collection and Storage Studies on both hCG negative and hCG positive urine specimens validated the VicTorch hCG Test Card devices when tested for urine specimens refrigerated for up to three days. (5) Accuracy studies at an external OBGYN clinical center on 172 female patients (with 91 hCG positive and 81 hCG negative) gave complete agreement (accuracy = 100%) with the ABI's SureStep hCG Test, the predicate approved hCG assay device. (6) In house stability study for both accelerated and real time evaluations showed that the performance of VicTorch hCG Test Card was stable for at least one year from the time of being manufactured. Support data collected from the above evaluation and accuracy studies (i.e., Relative Accuracy = Total # of VicTorch hCG Test Card agreeing with SureStep / vs. Total # of ABI SureStep tested x 100% = 172/172 x 100% = 100%, with at 95% Confidence = 99.1-99.8%) indicate substantial equivalence of this newly designed VicTorch hCG Test Card with the predicate approved hCG assay device.

We can conclude that VicTorch hCG Test Card devices are substantial equivalent to currently marketed ABI's SureStep hCG pregnancy rapid tests devices for professional use qualitative urinary assay of hCG at the required cut-off of 20 mlU/mL. Additional information on this submission may be obtained by contacting: Dr. Pierce Liu, President, at VicTorch Meditek, Inc, via Tel.: (858)-530-9191. Fax: (858)-530-9192. Email: Vtorch99@aol.com.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 7 2001

VicTorch Meditek, Inc. c/o Raymond Wilson, Pharm. D. California Department of Health 714/744 P Street P.O. Box 942732 (MS-357) Sacramento, CA 94234-7320

Re: K013678

Trade/Device Name: VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card Assay (VicTorch hCG Test Card) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (hCG) test system Regulatory Class: Class II Product Code: JHI Dated: December 12, 2001 Received: December 13, 2001

Dear Dr. Wilson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 801); 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.

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Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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510k Submission for VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Preqnancy Test Card Device

VicTorch Meditek, Inc.

Proprietary Information

Revision B, September 19, 2001

Identity of The Classification: 21 CFR 862.1155;

K013678
Product Code: DHA

Device Name: VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card Assay (VicTorch hCG Test Card)

INDICATIONS FOR USE STATEMENT:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jlan Cocer

Division Sign-Off)
vision of Clinical Laboratory

K013678

Prescription Use: or (Per 21 CFR 801.109)

Over-the-Counter Use: (Optional Format 1-2-96)

ર (દ

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.