QuPID® Plus E.R. pregnancy device is intended for qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.

Device Description

The test is comprised of colored dye coated with polyclonal antibodies specific for hCG, immobilized antibodies against hCG and monoclonal anti-mouse lgG antibodies. The assay is conducted by adding specimen, urine or serum, to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody hCG colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

AI/ML Overview

The QuPID® Plus E.R. pregnancy device is intended for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.

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 Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Accuracy	High concordance with a commercially available (predicate) test.	100% concordance with a commercially available test for both urine (n=300) and serum (n=72) specimens.
Specificity	No cross-reactivity with hLH, hFSH, and hTSH at specified concentrations.	No cross-reactivity observed with hLH (500 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/mL).
Sensitivity	Detect hCG at a clinically relevant threshold.	Detects hCG concentration of 10 mIU/mL or greater in serum and 20 mIU/mL in urine.
Standardization	Standardized to an international reference.	Standardized to the World Health Organization (WHO) Third International Standard.
Clinical Performance	High concordance with other commercially available tests in diverse settings.	100% concordance with other commercially available tests observed in clinical studies at three locations with diverse personnel.

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

Test Set Sample Size:
- Accuracy Study: 300 urine specimens and 72 serum specimens.
- Specificity Study: Not explicitly stated, but implies positive and negative urine/serum specimens were used after addition of interfering substances.
- Sensitivity Study: Not explicitly stated, but implied by the detection thresholds (10 mIU/mL in serum, 20 mIU/mL in urine).
- Clinical Studies: Not explicitly stated, but the results showed 100% concordance with other tests. Given the statement of 100% concordance, this would imply a sufficient sample size to establish this, though the exact number is missing for the overall clinical studies.
Data Provenance: The document does not specify the country of origin of the data. It appears to be a retrospective comparison study against a predicate device.

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

The document does not explicitly state the number of experts or their qualifications used to establish the "ground truth" for the test set. Instead, the "ground truth" for comparative effectiveness was established by the results from a "commercially available urine/serum membrane test" (predicate device) and "other commercially available tests" for the clinical studies. The performance of these predicate devices is assumed to be the reference standard.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The study design primarily involved comparing the QuPID® Plus E.R. results directly with the results of the predicate devices. The "ground truth" was established by the predicate device's output.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device itself compared to predicate devices, not on the improvement of human readers with or without AI assistance. This device is a rapid diagnostic test (RDT), not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone Performance

Yes, a standalone performance assessment was done. The accuracy, specificity, and sensitivity studies directly evaluated the QuPID® Plus E.R. device's performance characteristics independently, using predicate devices as internal controls or reference standards. The "100% concordance" specifically speaks to its standalone ability to yield results consistent with established methods.

7. Type of Ground Truth Used

The primary type of "ground truth" used was comparison to a predicate device / commercially available test. For the accuracy and clinical studies, the results from established, legally marketed pregnancy tests served as the reference. For specificity, spiked samples with known interfering substances were used. For sensitivity, likely samples with known hCG concentrations were used (though not explicitly detailed how these were prepared/validated).

8. Sample Size for the Training Set

The document does not mention separate "training sets" or "test sets" in the context of machine learning. This is a traditional in-vitro diagnostic device, not an AI/ML-based device. Therefore, the concept of a training set as understood in AI development is not applicable here. The "training" of the device is inherent in its manufacturing and quality control processes to ensure it meets performance specifications.

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

As explained above, there is no "training set" in the AI/ML sense for this device. The ground truth for establishing the device's operational parameters (e.g., antibody concentrations, conjugate characteristics) would have been based on established biochemical principles, antigen-antibody interactions, and calibration against international standards like the WHO Third International Standard for hCG.

Summary

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K020378

JUN 2 1 2002

510(k) Summarv QuPID® Plus E.R.

QuPID® Plus E.R. pregnancy device is intended for qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. The test is comprised of colored dye coated with polyclonal antibodies specific for hCG, immobilized antibodies against hCG and monoclonal anti-mouse lgG antibodies. The assay is conducted by adding specimen, urine or serum, to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody hCG colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

Classification Name:	Gonadotropin
Classification Number:	75DHA, Class II

Predicate Device: Abbott Test Pack® Plus

PERFORMANCE CHARACTERISTICS

Accuracy:

An evaluation was conducted comparing the results obtained using QuPID® Plus E.R. and another commercially available urine/serum membrane test. The study included 300 urine and 72 serum specimens tested with both assays. The following results were found:

	Positive UrineResults	Negative UrineResults
QuPID® Plus E.R.	150	150
CommerciallyAvailable Test	150	150
	Positive SerumResults	Negative SerumResults
QuPID® Plus E.R.	21	51
CommerciallyAvailable Test	21	51

QuPID® Plus E.R. showed a 100% concordance with the other commercially available test for accuracy.

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510(k) Summary QuPID® Plus E.R. cont'd

Specificity:

The addition of hLH (500 mlU/ml), hFSH (1000 mlU/ml), and hTSH (1000 µlU/mL), to positive and negative urine/serum specimens showed no cross-reactivity.

Standardization:

The test has been standardized to the World Health Organization Third International Standard.

Sensitivity:

QuPID® Plus E.R. detects hCG concentration of 10 mlU/mL or greater in serum and 20 mIU/mL in urine.

CLINICAL STUDIES

Clinical Studies were conducted at three locations. The tests were conducted by individuals of diverse educational backgrounds and work experience. The results of these studies showed a 100% concordance with other commercially available tests.

CONCLUSION

The QuPID® Plus E.R. is substantially equivalent in principle and performance to Abbott's Test Pack® Plus as shown in this summary.

Summary prepared by Kirk Johnson, QA/QC Manager on January 30, 2002 Stanbio Laboratory 1261 North Main Street Boerne, Texas 78006

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 1 2002

Mr. Kirk Johnson QA/QC Manager Stanbio Laboratory 1261 North Main Street Boerne, TX 78006

Re: K020378

Trade/Device Name: QuPID Plus E.R. Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: April 25, 2002 Received: April 26, 2002

Dear Mr. Johnson:

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 (OS) 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 1 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/cdrh/dsma/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

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Page 2 of 38

510(k) Number (if known):	K020378
Device Name:	QuPID Plus E.R.

Indications For Use:

QuPID Plus E.R. is for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.

Fran
Crop
(Division Sign-Off)
Division of Clinical Laborator evices
510(k) Number 020378

(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) $\checkmark$

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.