(81 days)
The AZOG hCG One-Step (Urine) Pregnancy Test (Device or Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
AZOG, INC. hCG One-Step Urime Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine The test is for professional use only.
The AZOG hCG One-Step Pregnancy Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine into the sample well of the 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 antibody-hCG-colored conjugate to 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.
Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity (Detection limit of hCG) | Detects hCG at 25 mIU/mL or greater. |
| Specificity (No cross-reactivity with other hormones) | No cross-reactivity observed with LH (1000 mIU/mL), FSH (1000 mlU/mL), and TSH (1000 ulU/mL) at both negative (0 mlU/mL hCG) and positive (25 mIU/mL hCG) levels. |
| Overall Agreement/Accuracy (Compared to a similar device) | 100% overall agreement with a similar device. |
| Assay Precision/Tolerance (Reproducibility within and between runs/operators) | No differences observed within run (5 replicates), between runs (three different assay days), or between operators (two operators) for negative, low positive, and high positive specimens. |
| Interference (No interference from potentially interfering substances) | None of the potentially interfering substances tested interfered with the assay. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 150 urine specimens were used for the correlation study. For the precision/tolerance study, a panel of 3 coded specimens (negative, low positive, and high positive) were tested.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective, as they involve testing the device with specific specimens to evaluate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. For the correlation study, the "ground truth" was established by comparing the results of the AZOG device to a "similar device," implying that the similar device's results were considered the reference.
4. Adjudication Method for the Test Set
The document does not detail an adjudication method. For the correlation study, it was a direct comparison of results to a "similar device." For precision, it was an assessment of consistency across runs and operators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the device and its agreement with a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The document describes the device's ability to detect hCG, its sensitivity, specificity, precision, and freedom from interference, all of which are characteristics of the device's inherent performance. The "Correlation" study compared the device's results to another device, essentially evaluating its standalone accuracy.
7. The Type of Ground Truth Used
- For the correlation study, the ground truth was established by the results obtained from a similar, presumably already validated, device.
- For sensitivity, the ground truth was based on known concentrations of hCG (25 mIU/mL or greater).
- For specificity, the ground truth was based on known concentrations of other hormones (LH, FSH, TSH) in both negative and positive hCG specimens.
- For precision/tolerance, the ground truth involved coded specimens with known (negative, low positive, high positive) hCG status to assess consistency.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device development or machine learning. For traditional immunoassay devices, there isn't a separate training set in the same way there would be for an AI/ML algorithm. The development of the device's reagents and design would implicitly use various samples during the R&D phase, but these are not typically referred to as a "training set" in regulatory submissions for these types of devices.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is explicitly mentioned for this type of immunoassay device, the method for establishing its ground truth is not applicable. The device's performance relies on the biochemical specificity of its antibodies and the design of the assay, rather than learned patterns from a training dataset.
{0}------------------------------------------------
510(k) SUMMARY
1 2002
DEVICE NAME: AZOG,Inc. One-Step Urine Pregnancy Test (Device or Cassette).
NOV
| APPLICANT NAME: | AZOG, Inc.1011 US HWY 22 WESTPHILLIPSBURG, NJ 08865 |
|---|---|
| CONTACT: | AZUBUIKE OGALATel.: (908) 213-2900Fax: (908) 213-2901 |
INTENDED USE:
The AZOG hCG One-Step (Urine) Pregnancy Test (Device or Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
DESCRIPTION OF THE DEVICE
The AZOG hCG One-Step Pregnancy Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine into the sample well of the 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 antibody-hCG-colored conjugate to 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.
40
{1}------------------------------------------------
DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE:
Assay Precision/Tolerance
An evaluation of AZOG. Inc. hCG One-Step Urine Pregnancy Test (Device or Cassette) was conducted using a panel of 3 coded specimens. The proficiency panel contained negative, low positive and high positive specimens. Two different operators tested each level in replicates of five over a period of three days.
No differences were observed within run (5 replicates), between runs (three different assay days), or between operators (two operators).
Correlation
A total of 150 urine specimens were tested using the AZOG, Inc. hCG One Step Urine Pregnancy Test (Device or Cassette). When these results were compared to results obtained from a similar device, the result demonstrated 100% overall agreement (for an accuracy of greater than or equal to 99%) of the AZOG, Inc. hCG One-Step Urine Pregnancy Test (Device or Cassette).
Sensitivity and Specificity
The AZOG. Inc. hCG One-Step Urine Pregnancy Test (Device or Cassette) detects hCG at 25 mIU/mL or greater. The test has been standardized to the W.H.O. Third International Standard. The addition of LH (1000 mIU/mL), FSH (1000 mlU/mL) and TSH (1000 ulU/mL) to negative (0 mlU/mL. hCG) and positive (25 mIU/mL hCG) specimens showed no cross-reactivity.
Interference Study
None of the potentially interfering substances tested interfered in the AZOG, Inc. hCG One-Step Urine Pregnancy Test (Device or Cassette) assay.
AZOG, Inc. bCG One-Step Urine Pregnancy Test (Device or Cassette)
41
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. The logo is simple and recognizable, and it is used on a variety of official documents and websites.
od and Drug Administra 98 Gaither Road ckville MD 20850
Mr. Azubuike Ogala President/V.P., Research & Development Azog Incorporated 1011 US HWY 22 . Phillipsburg, NJ 08865
K022681 Re:
Trade/Device Name: ACG One-Step Urine Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: DHA Dated: August 1, 2002 Received: August 12, 2002
Dear Mr. Ogala:
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. Iisting 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.
{3}------------------------------------------------
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/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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
{4}------------------------------------------------
510(k) Number (if known): K022681
Device Name: ACG ONE-STEP
URINE PREGNANCY TEST
Indications For Use:
AZOG, INC. hCG One-Step Urime Pregnancy test is
intended for the qualitative determination of
Human Chorionic Gonadotropin (hCG) in Human Urine
The test is for professional use only.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1122661
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OK
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Formal 1-2-96)
SK 4t
§ 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.