The Test is a qualitative immunoassay intended for non professional / Over The Counter Use for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.

Device Description

A single step, visually read, qualitative immuno-chromatographic single use stick test.

AI/ML Overview

Here's an analysis of the provided information, focusing on acceptance criteria and the study detailing device performance:

Acceptance Criteria and Device Performance for Mid Stream Pregnancy Test (K023037)

The document focuses on demonstrating the substantial equivalence of the Mid Stream Pregnancy Test to a predicate device, rather than establishing de novo acceptance criteria. The primary "acceptance criteria" presented are the device's ability to correlate 100% with the predicate device and the high repeatability and precision observed in various studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Correlation with Predicate Device: 100% agreement with legally marketed predicate device	100% correlation between Mid Stream Pregnancy Test and predicate device
Repeatability: High consistency of results when tested by different personnel and settings	100% agreement in POL study and consumer evaluation
Precision: Highly consistent results upon repeated testing	>99% precision
Ease of Use/Understanding (Consumer): Simple, fast, convenient, easy to understand by consumers	>99% of consumers found the test to be simple, fast, convenient, easy to understand, and accurate
Safety and Effectiveness: As safe and effective as a legally marketed OTC device for pregnancy testing	Concluded to be safe, as effective, and performs as well as the legally marketed OTC device

2. Sample Sizes and Data Provenance

Test Set (Correlation Study):
- Sample Size: Not explicitly stated for the "comparison studies" against the predicate device. However, the subsequent "consumer study" used 115 consumers.
- Data Provenance: The document does not specify the country of origin. The studies appear to be prospective evaluations for the purpose of this 510(k) submission.
POL Study (Point-of-Care/Laboratory Study):
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated. The study involved "different personnel with diverse educational background and work experience," suggesting it was conducted within a controlled (lab or clinical) environment. It's likely prospective.

3. Number of Experts and Qualifications for Ground Truth

Correlation Study & POL Study:
- The document implies that the predicate device's results served as a form of ground truth for the correlation study. The "different personnel with diverse educational background and work experience" involved in the POL study would have been trained professionals, but their exact number or specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. They are referred to as "professionals" in contrast to "consumers."
Consumer Study:
- The results obtained from "professionals" served as the ground truth against which consumer results were compared. The number and specific qualifications of these professionals are not stated.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1 or 3+1). For the core comparison/correlation studies, the method appears to be a direct comparison of the new device's results to the predicate device's results. For the consumer study, the "professionals" likely provided the definitive interpretation, against which consumer interpretations were measured.

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

No Multi Reader Multi Case (MRMC) comparative effectiveness study is mentioned. The comparison is between the new device and a predicate device, and between consumers and professionals, rather than evaluating human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

This device is an immuno-chromatographic stick test, not an algorithm or software. Therefore, the concept of a "standalone" algorithm-only performance study does not apply. The performance described is the standalone performance of the physical test device.

7. Type of Ground Truth Used

Correlation Study: The results from the predicate device (Acon Midstream Pregnancy Test, K983090) served as the primary ground truth.
POL Study & Consumer Study: The results obtained by trained professionals using the device (or the predicate device) were used as the ground truth against which other interpretations (e.g., consumer interpretations) were compared. This is a form of expert consensus/professional standard.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or machine learning. For this type of diagnostic test, the "training" typically refers to the development and optimization of the assay itself, which is not detailed in terms of sample sizes here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of an algorithm, this question is not applicable. The development process would have involved establishing the assay's sensitivity and specificity against known positive and negative samples, but the specifics of how this 'ground truth' was established during development are not provided.

Summary

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K023037

Advanced Diagnostics, Inc.

APR 0 9 2003

510 (k) Summary

Submitter	Name and address	Advanced Diagnostics, Inc.(Division of Inamco Group ofCompanies)801 Montrose AvenueS. PlainfieldNJ 07080908 754 4880 (Tel)908 754 5181 (Fax)
	Contact Person:	Dr. D. M. Chouhan
	Date Prepared:	11 September 2002
Device name:	Trade Name: Mid Stream Pregnancy Test
	Common Name: Human Chorionic Gonadotropin(hCG) Test
	Classification Name: 21 CFR section 862.1155,Class II. - A qualitative HumanChorionic Gonadotropin (hCG)test system.
Predicate Device	The Mid Stream Pregnancy Test is substantiallyequivalent to other legally marketed devices for thesimilar intended use. The device used for comparisonstudy is Acon Midstream Pregnancy Test made byAcon Laboratories, Inc. having a 510K #.K983090.
Device Description	A single step, visually read, qualitative immuno-chromatographic single use stick test.
Intended Use	The Mid Stream Pregnancy test is a home pregnancyurine test designed for qualitative detection of thehuman chorionic gonadotropin (hCG) in urine. The testis for use as an aid in the diagnosis of early pregnancy.
	4-1	Continued.........2

801 Montrose Avenue, S. Plainfield, NJ 07080 USA Tel: 908 754 4880 Fax: 908 754 5181 e mail : cs@inamco.com

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Advanced Diagnostics, Inc.

(2)

Summary of the · The intended use and performance characteristics : Both devices are OTC devices intended to use for an Similarities to the early detection of hCG in human urine. Predicate device Technological characteristics: . Both devices are one step, qualitative, visual lateral flow immuno-chromatographic test in a sandwich complex format of anti hCG antibody / hCG/ antihCG 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 The comparison studies demonstrated that there was . Conclusion 100% correlation between the results obtained by Mid Stream Pregnancy Test and the predicate device. It indicates that the Mid Stream Pregnancy test is substantially equivalent to the predicate device. . The POL study and the evaluation carried out by different personnel with diverse educational background and work experience agreed 100% with the results expected, indicating that the testing results are highly repeatable. The precision of the test was found to be >99%. . The consumer study carried out with 115 consumers demonstrated that the results obtained from consumers agreed 100% with that obtained from

professionals. No discrepancy was found between the results obtained by Mid Stream Pregnancy Test and the predicate device. Over 99% of the consumers found the Mid Stream Test to be simple. fast, convenient, easy to understand and accurate.
Continued............3

4-2

801 Montrose Avenue, S. Plainfield, NJ 07080 USA Tel: 908 754 4880 Fax: 908 754 5181 e mail : cs@inamco.com

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Advanced Diagnostics, Inc.

(3)

. Based on the results of the consumer study, correlation study and the POL evaluations. we may conclude that Mid Stream Pregnancy Test is safe, as effective and performs as well as the legally marketed OTC device. It's intra and inter-assay precision is >99%. Therefore this device is suitable for use as an OTC Pregnancy Test.
4-3

801 Montrose Avenue, S. Plainfield, NJ 07080 USA Tel: 908 754 4880 Fax: 908 754 5181 e mail : cs@inamco.com

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines that resemble a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 0 9 2003

Dr. D. M. Chouhan President Advanced Diagnostics, Inc. 801 Montrose Avenue South Plainfield, NJ 07080

Re: K023037 Trade/Device Name: Mid Stream Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: February 5, 2003 Received: February 6, 2003

Dear Dr. Chouhan:

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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Page 2 --

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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use

510 (k) NUMBER (if KNOWN) : _ KO 2 303 1

Mid Stream Pregnancy Test DEVICE NAME :

INDICATIONS FOR USE :

Sean Cooger

(Divis
Division Clinical Laboratory Devices
510(k) number K023037

( PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDE. )

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription Use ( Per 21 CFR 801.109 )

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.