(81 days)
The AZOG hCG One-Step (Urine) Pregnancy Test Strip (DipStick) 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. ACG one-step. Vrine 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 Strip (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 immersing the test strip in a urine specimen 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 study details for the AZOG,Inc. Urine Pregnancy Test Strip:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Agreement | 100% (with a similar predicate device) |
| Accuracy | ≥ 99% |
| Sensitivity (Detection Limit) | Detects hCG at 25 mIU/mL or greater |
| Cross-Reactivity (LH, FSH, TSH) | No cross-reactivity at 1000 mIU/mL LH, 1000 mIU/mL FSH, and 1000 µIU/mL TSH |
| Interference | None of the potentially interfering substances tested interfered |
| Precision/Tolerance (Within-run) | No differences observed across 5 replicates |
| Precision/Tolerance (Between-run/Day) | No differences observed across three different assay days |
| Precision/Tolerance (Between-operator) | No differences observed between two operators |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 150 urine specimens were used for the correlation study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document only mentions "a panel of 3 coded specimens" for precision/tolerance and "150 urine specimens" for correlation. Given the nature of a pregnancy test, these would typically be human urine samples.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable or not specified. For this type of device, the "ground truth" is typically established by comparing its results to a known reference method or a predicate device, rather than expert interpretation of images or clinical data.
- Qualifications of Experts: Not applicable, as expert consensus was not the primary method for ground truth establishment.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for the correlation study was established by comparing the device's results to those obtained from a "similar device," implying either a predicate device or a well-established laboratory method. There was no mention of multiple human readers or a need for adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study (MRMC) is typically performed for imaging diagnostic devices where human interpretation plays a significant role and AI aims to assist or replace human readers. The AZOG hCG One-Step Urine Pregnancy Test Strip is a rapid immunoassay that provides a direct qualitative result, not requiring a human interpretation loop in the same way.
- Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Yes, essentially. The stated performance metrics (100% overall agreement, 99% accuracy, sensitivity, specificity, cross-reactivity, interference, precision) reflect the standalone performance of the device itself (the "algorithm" in a chemical assay context) reacting with urine samples. The device is designed to provide a direct readout without requiring human intervention for result interpretation beyond observing the colored lines.
7. Type of Ground Truth Used
- Ground Truth Type:
- Correlation Study: Comparison to results obtained from a "similar device" (likely a legally marketed predicate device or a validated laboratory method).
- Sensitivity: Defined by the ability to detect a specific concentration of hCG (25 mIU/mL or greater) in spiked samples. This is a form of analytical ground truth.
- Cross-Reactivity/Interference: Determined by testing known concentrations of interfering substances with negative and positive hCG samples. This is also analytical ground truth.
- Precision/Tolerance: Established by testing coded specimens with known hCG levels (negative, low positive, high positive). This involves using known spiked/controlled samples as ground truth.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. For this type of immunoassay, there isn't a "training set" in the machine learning sense. The device's performance is based on its chemical and biological components, which are developed and optimized through laboratory testing, rather than an AI algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the context of an AI training set. The development and optimization of the immunoassay (analogous to "training") would involve internal validation using known concentrations of hCG, potentially spiked with interferents, and comparison to established reference methods or predicate devices to ensure the assay components (antibodies, membrane, reagents) function as intended. This would involve a continuous process of testing and refinement during product development.
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1 2002 NOV
16022680
510(k) SUMMARY
DEVICE NAME: AZOG,Inc. Urine Pregnancy Test Strip (DipStick).
| APPLICANT NAME: | AZOG, Inc. 1011 US HWY 22 WEST PHILLIPSBURG, NJ 08865 |
|---|---|
| CONTACT: | AZUBUIKE OGALA Tel.: (908) 213-2900 Fax: (908) 213-2901 |
INTENDED USE:
The AZOG hCG One-Step (Urine) Pregnancy Test Strip (DipStick) 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 Strip (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 immersing the test strip in a urine specimen 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.
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AZOG, Inc. hCG One-Step Urine Pregnancy Test Strip (DipStick)
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DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE:
Assay Precision/Tolerance
An evaluation of AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick) 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. hCO One-Step Urine Pregnancy Test (DipStick). 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. bCG One-Step Urine Pregnancy Test (DipStick).
Sensitivity and Specificity
The AZOG, Inc. hCG One-Step Urine Pregnancy Test (DipStick) detects hCG at 25 mlU/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 mIU/mL) and TSH (1000 µIU/mL) to negative (0 mIU/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 (DipStick)assay.
AZOG, Inc. bCG One-Step Urine Preguancy Test Strip (DipStick)
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DEPARTMENT OF HEALTH & HUMAN SERVIC
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three curved lines representing the eagle's wings and three wavy lines representing the eagle's body.
18 Garner Road
Mr. Azubuike Ogala President/V.P., Research & Development Azog Incorporated 1011 US HWY 22 Phillipsburg, NJ 08865
K022680 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:
Re:
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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (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/cdrl/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
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022680 510(k) Number (if known):
Device Name: hCG ONE-STEP
GNANC
Indications For Use:
AZOG, INC. ACG one-step. Vrine 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 K022680
(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)
OK
Over-The-Counter Use_
· of
(Optional Format 1-2-96)
SK47
§ 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.