Innovacon™ hCG Ultra Test Device is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. It is for healthcare professionals only.

Device Description

The test utilizes a combination of antibodies including mouse monoclonal antihCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding urine or serum specimens to the specimen well of the test device and observing 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 colored antibody conjugates and form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

The Innovacon™ hCG Ultra Test Device is a rapid test that qualitatively detects hCG at the sensitivity of 10 mIU/mL in serum and 20 mIU/mL in urine. The cutoff concentration of this test has been standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589). At the level of claimed sensitivity, the hCG Ultra Test Device shows no cross-reactivity interference from the structurally related glycoprotein hormones FSH, LH and TSH at extra high physiological levels.

AI/ML Overview

The provided text describes the Innovacon™ hCG Ultra Test Device, a pregnancy test kit for professional use, and its 510(k) clearance (K062361). The clearance document confirms the device's substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" as a formal table with quantitative targets. Instead, it describes performance characteristics and claims substantial equivalence to a predicate device. The primary "acceptance criteria" appear to be:

Qualitative detection of hCG in serum or urine.
Sensitivity: 10 mIU/mL in serum and 20 mIU/mL in urine.
No cross-reactivity with FSH, LH, and TSH at extra high physiological levels.
Robustness and accurate results under adverse conditions (referring to various laboratory studies).
Ease of use, clear labeling, and interpretable results.

Here's a table summarizing the performance claims:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Qualitative detection of hCG in serum or urine for early pregnancy detection.	"Qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy."
Sensitivity	Specific thresholds for serum and urine detection.	"Qualitatively detects hCG at the sensitivity of 10 mIU/mL in serum and 20 mIU/mL in urine." (Standardized to WHO Fourth International Standard).
Specificity/Interference	No cross-reactivity with related hormones; robustness against interfering substances.	"Shows no cross-reactivity interference from the structurally related glycoprotein hormones FSH, LH and TSH at extra high physiological levels." "Additional laboratory study results on performance including specificity, interference substances, urinary pH, urinary specific gravity, dose hook effect, time flexibility, and sample volume flexibility studies... indicate that the Innovacon hCG Ultra Test Device is robust and will give accurate results under many adverse conditions."
Reproducibility & Precision	High degree of reproducibility and precision.	"The POL study demonstrated high degree of reproducibility and precision of the Innovacon hCG Ultra Test Device."
Ease of Use/Interpretability	Easy to use, understandable labeling and instructions, interpretable results.	"The POL sites also found the Innovacon hCG Ultra Test Device very easy to use, and that they have had no trouble understanding the labeling, reading the instructions, or interpreting the results."
Substantial Equivalence	Equivalent performance to predicate device.	"A clinical study... demonstrated performance equivalency between the Fisher Sure-Vue Serum/Urine hCG-STAT test and the Innovacon hCG Ultra Test Device by professionals." "The overall performance data indicate that the Innovacon hCG Ultra Test Device is safe, effective and substantially equivalent to the Fisher Sure-Vue Serum/Urine HCG-STAT legally sold in the U. S. market."

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

The text refers to a "clinical study" and "POL study" (presumably referring to Point-of-Care/Limited laboratory settings), but does not specify the sample size for these studies.

Data Provenance: The clinical study was "conducted in three sites in the U.S." This indicates the data is from the United States and appears to be prospective, as it was conducted specifically to evaluate the new device.

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

The document does not specify the number of experts used or how ground truth was established for the clinical study. It mentions the study was conducted by "healthcare professionals with varying educational backgrounds and laboratory experience." This suggests general healthcare professionals were involved but doesn't detail their qualifications for establishing a definitive ground truth for hCG levels.

4. Adjudication Method for the Test Set

The text does not describe any adjudication method (e.g., 2+1, 3+1, none) for reconciling discrepancies or establishing a definitive ground truth in the clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The document describes a "performance equivalency" study comparing the Innovacon device to the Fisher Sure-Vue Serum/Urine hCG-STAT test. It states this was done "by professionals," implying human readers were involved. However, it does not explicitly state that it was an MRMC study designed to measure the effect size of human readers improving with or without AI assistance. This is a rapid immunoassay, not an AI-powered diagnostic imaging device, so conventional MRMC studies measuring AI assistance are not applicable. The comparison here is between two different test kits as interpreted by human users.

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

This question is not applicable to this device. The Innovacon hCG Ultra Test Device is a rapid chromatographic immunoassay, which is a physical test kit requiring human interpretation of colored lines, not an algorithm or AI system. Its performance is inherently linked to human-in-the-loop steps (applying samples, reading results).

7. The Type of Ground Truth Used

The type of ground truth is not explicitly stated. Given that it's a pregnancy test, the ground truth would typically be established by:

Laboratory reference methods: More sensitive and quantitative hCG assays (e.g., quantitative serum hCG).
Clinical outcomes: Confirmation of pregnancy via ultrasound or other clinical signs.
Predicate device results: In the context of a substantial equivalency claim, the results from the predicate device (Fisher Sure-Vue Serum/Urine hCG-STAT) would serve as a comparative ground truth.

The document states the device's cutoff concentration was "standardized to the World Health Organization Fourth International Standard for Chorionic Gonadotropin (NIBSC Code: 75/589)," indicating a scientific basis for the hCG levels.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is consistent with a traditional immunoassay device, which does not typically involve machine learning requiring training data. The "training" in this context would likely refer to the development and optimization of the assay components and parameters.

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

As there is no explicit mention of a training set in the AI/ML sense, this question is not applicable. The development of the assay's sensitivity and specificity would have been based on established medical and biological principles for detecting hCG, potentially using characterized hCG samples standardized to international references.

Summary

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K062361

Conclusion:

OCT 2 3 2006

Applying 2 to 6 drops of samples to the Innovacon hCG Ultra Test Devices yielded correct results as read at 3 or 5 and 10 minutes after sample application. However, Innovacon recommends using 3 drops of the urine or serum sample to obtain the best test result, as prescribed in our package insert.

XV. 510(k) Summary

Device Names:

Innovacon™ hCG Ultra Test Device

Common Name:

Pregnancy Test Kit, Professionals

Medical Specialty:

Clinical Chemistry

Intended Use:

The Innovacon™ hCG Ultra Test Device is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. It is for professional in-vitro diagnostic use only

Device Description:

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shows no cross-reactivity interference from the structurally related glycoprotein hormones FSH, LH and TSH at extra high physiological levels.

Clinical Studies:

A clinical study was conducted in three sites in the U.S. by healthcare professionals with varying educational backgrounds and laboratory experience and demonstrated performance equivalency between the Fisher Sure-Vue Serum/Urine hCG-STAT test and the Innovacon hCG Ultra Test Device by professionals. The POL study demonstrated high degree of reproducibility and precision of the Innovacon hCG Ultra Test Device

The POL sites also found the Innovacon hCG Ultra Test Device very easy to use, and that they have had no trouble understanding the labeling, reading the instructions, or interpreting the results.

Additional Laboratory Studies:

Additional laboratory study results on performance including specificity, interference substances, urinary pH, urinary specific gravity, dose hook effect, time flexibility, and sample volume flexibility studies are also included in this submission. These results indicate that the Innovacon hCG Ultra Test Device is robust and will give accurate results under many adverse conditions.

Substantial Equivalency on Performance:

The overall performance data indicate that the Innovacon hCG Ultra Test Device is safe, effective and substantially equivalent to the Fisher Sure-Vue Serum/Urine HCG-STAT legally sold in the U. S. market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with flowing lines, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward Tung, Ph.D. Vice President, Regulatory Affairs Innovacon Inc 4106 Sorrento Valley Blvd. San Diego, CA 92121

OCT 2 3 2006

Re: K062361 Trade/Device Name: Innovacon™ hCG Ultra Test Device Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: August 11, 2006 Received: August 14, 2006

Dear Dr. Tung:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Alberto Garcia

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use V.

510(k) Number (if known): K062361

Device Name:

Innovacon™ hCG Ultra Test Device

"Indications for Use":

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety Evaluation and Safety

K062361

Page 1 of

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.