ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY by GERMAINE LABORATORIES, INC.

AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is intended for non-professional over-the-counter use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

Device Description

The test utilizes a combination of monoclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored liness. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specific antibody-hCG-colored conjugate and form a colored line on the Specimen portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Zone will always appear regardless of the presence or absence of hCG.

AI/ML Overview

Here's an analysis of the provided text regarding the AccuDip™ Home Pregnancy Test, formatted to address your specific questions:

AccuDip™ Home Pregnancy Test Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Detects hCG concentrations of 20 mIU/ml and greater.	"The AccuDip™ Home Pregnancy test detects hCG concentrations of 20 mIU/ml and greater."
No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) in negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine.	"The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity."
Ease of use for non-professional users.	"The majority of the participants found AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy very easy to use."
Understandability of labeling and instructions for non-professional users.	"They had no trouble understanding the labeling, reading the instructions..."
Interpretability of results for non-professional users.	"...or interpreting the results."
Overall suitability for over-the-counter pregnancy testing.	"The overall results of the clinical trial confirm that AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is a suitable test for over-the-counter pregnancy testing."

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

Sample Size for Test Set: 73 female participants.
Data Provenance: The document does not specify the country of origin. It can be inferred to be a prospective clinical trial given the description of "clinical trials using AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy were conducted which included 73 female participants."

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

The document does not provide information on the number of experts or their qualifications used to establish the ground truth for the test set. It describes a "clinical trial" but does not detail how pregnancy status (ground truth) was definitively determined for the 73 participants.

4. Adjudication Method (for the test set)

The document does not specify any adjudication method for establishing the ground truth of the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic test for self-use, not a medical imaging or diagnostic interpretation system designed for human readers.

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

Yes, the primary "performance" described pertains to the standalone device's ability to detect hCG and its analytical specificity, as well as user comprehension. The test itself is designed for standalone use by consumers.

7. The Type of Ground Truth Used

The document broadly refers to "clinical trials" and the "determination of pregnancy." For the analytical performance (hCG detection and cross-reactivity), it implies:

Known hCG concentrations: For the "detection of hCG concentrations of 20 mIU/ml and greater." This would likely involve spiked samples or serially diluted known positive samples.
Known concentrations of interferents: For the cross-reactivity study with hLH, hFSH, and hTSH, likely using samples with known concentrations of these hormones and known hCG status (0 mIU/ml or 20 mIU/ml).
For the user study with 73 participants, the ground truth for "pregnancy status" is not explicitly stated but would ideally be confirmed by a gold standard method (e.g., laboratory quantitative hCG test) a short time after the home test. The focus of this part of the study seems to be on user comprehension and ease of use, not necessarily the diagnostic accuracy of the device against a clinical gold standard performed at the same time.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This type of diagnostic device (lateral flow immunoassay) typically does not involve machine learning or AI models with distinct "training" and "test" sets in the way that software algorithms do. The development and validation process focuses on analytical performance and clinical evaluation.

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

As there is no mention of a training set in the context of machine learning, this question is not applicable. The ground truth for the analytical and clinical studies described in the summary would have been established through laboratory controls (known concentrations) and, presumably, standard clinical methods for pregnancy determination.

Summary

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K991369⊕

"Summary of Safety & Effectiveness"

The AccuDip™ Home Pregnancy Test and/or AimStick™ Pregnancy is intended for non-professional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monoclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored liness. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specific antibody-hCG-colored conjugate and form a colored line on the Specimen portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Zone will always appear regardless of the presence or absence of hCG.

The AccuDip™ Home Pregnancy test detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organizational Standard. The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.

Clinical trials using AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy were conducted which included 73 female participants. The results of the study showed that the majority of the participants found AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy very easy to use, and that they had no trouble understanding the labeling, reading the instructions, or interpreting the results.

The overall results of the clinical trial confirm that AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is a suitable test for over-the-counter pregnancy testing

Maitre O'connor

4-14-94
Date

K991369

arket Notification 510(k) Number

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

MAY 1 0 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardendale Center, #230 San Antonio, TX 78229

Re: K991369 Trade Name: AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy Regulatory Class: II Product Code: LCX Dated: April 19, 1999
Received: April 20, 1999

Dear Mr. O'Connor:

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.

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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/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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Indications For Use

510(k) Number: K991369

Device Name: AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy

"Indications For Use" -

Sean Cooper
Division Sign-Off)

Trision of Clinical Laboratory Devices 510(k) Number

(Please do not write below this point)

Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Usc (per 21 CFR 801.109) or

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.