(43 days)
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No
The device description details a lateral flow immunoassay that relies on chemical reactions and visual interpretation of colored bands, with no mention of AI or ML components.
No
Explanation: A therapeutic device is used for treating or curing a disease or condition. This device is a diagnostic tool for determining pregnancy and does not provide any treatment.
Yes
The device is described as aiding "in the determination of pregnancy" by identifying hCG, which is a diagnostic purpose.
No
The device description clearly outlines a physical test strip that utilizes antibodies and capillary action to detect hCG in urine, indicating it is a hardware-based diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to diagnose a condition (pregnancy).
- Device Description: The description details how the test works by reacting with components in the urine sample (hCG) using antibodies and producing a visual result (colored bands). This process is characteristic of many IVD tests.
- Performance Studies: The document describes a clinical evaluation where the device was tested with urine specimens to assess its performance compared to another commercially available test. This type of testing is required for IVD devices to demonstrate their accuracy and reliability.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.
Product codes
DHA
Device Description
The test utilizes a combination of momelonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. 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 and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence of hCG.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A multi-center clinical evaluation was conducted comparing the results obtained using AimStick® PBD Pregnancy and another commercially available test. The study included 150 urine specimens tested with both assays.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multi-center clinical evaluation was conducted comparing the results obtained using AimStick® PBD Pregnancy and another commercially available test. The study included 150 urine specimens tested with both assays. AimStick™ PBD Pregnancy showed a 100% concordance with the other commercially available test. AimStick™ PBD Pregnancy detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hI.H (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% concordance
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
*974 368
JAN.2,1978
"Summary of Safety & Effectiveness"
AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropia) in urine to aid in the determination of pregnancy. The test utilizes a combination of momelonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. 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 and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence of hCG.
A multi-center clinical evaluation was conducted comparing the results obtained using AimStick® PBD Pregnancy and another commercially available test. The study included 150 urine specimens tested with both assays. The following results were found:
| Positive Results | Negative Results | |
|---|---|---|
| AimStick™ | 78 | 72 |
| Commercially | ||
| Available Test | 78 | 72 |
AimStick™ PBD Pregnancy showed a 100% concordance with the other commercially available test.
AimStick™ PBD Pregnancy detects hCG concentrations of 20 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hI.H (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity.
Martin O'Connor, Regulatory Affairs
11-18-97
Date
Premarket Notification 510(k) Number
Image /page/0/Picture/10 description: The image shows a black and white drawing of a curved line. The line starts on the left side of the image and curves upwards and to the right. It then curves back down and to the left, forming a shape that resembles a stylized letter 'S'. The line is thick and bold, and it stands out against the white background.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
$$\text{מאַטער}\text{ - מען באַרשע }$$
Mr. Martin O'Connor General Manager Germaine Laboratories, Inc. 4203 Gardendale Center Suite 230 San Antonio, TX 78229
K974368 Re: Trade Name: AimStick™ PBD Pregnancy Regulatory Class: II Product Code: DHA Dated: November 18, 1997 Received: November 20, 1997
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 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 OS 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
3
Indications For Use
510(k) Number:_ K 974368
Device Name: AimStick™ PBD Pregnancy
"Indications For Use" -AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.
A+ AWM
(Division Sign-Off)
Division or Clinical Laboratory Devices
510(k) Number
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (per 21 CFR 801.109)
or
Over-The-Counter Use
2