(58 days)
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No
The device description details a rapid chromatographic immunoassay based on antibody reactions and capillary action, with no mention of computational analysis, algorithms, or learning processes.
No
A therapeutic device is used to treat or cure a disease or condition. This device is purely diagnostic, as it only detects hCG for early pregnancy detection and does not provide any treatment.
Yes
The device is described as an "aid for the early detection of pregnancy," which involves detecting the presence of hCG to diagnose a biological condition.
No
The device description clearly outlines a physical test device that utilizes chromatographic immunoassay and involves adding a specimen to the device and observing for colored lines. This indicates a hardware component is essential to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to gain information about a physiological state (pregnancy).
- Device Description: The description details a "rapid chromatographic immunoassay" that utilizes antibodies to detect a substance (hCG) in a specimen (urine). This is a classic description of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing urine specimens and comparing the results to another commercially available urine test. This further confirms its function as a diagnostic tool analyzing biological samples.
The definition of an In Vitro Diagnostic device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Detecting hCG in urine to aid in the early detection of pregnancy fits this definition.
N/A
Intended Use / Indications for Use
ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy.
Product codes
JHI
Device Description
ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for 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 and form a colored line in the Test Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence 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
Not-Found (Implied professional use by "This test is for 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 ACON™ hCG One Step Pregnancy Test Device (Urine) and another commercially available urine membrane test. The study included 159 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 ACON™ hCG One Step Pregnancy Test Device (Urine) and another commercially available urine membrane test. The study included 159 urine specimens tested with both assays.
ACON™ hCG One Step Pregnancy Test Device (Urine) showed a 100% concordance with the other commercially available test.
ACON™ hCG One Step Pregnancy Test Device (Urine) detects hCG concentrations of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300mUVml, hFSH (1000 mIU/ml), and hTSH (1000uIU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% concordance with another commercially available test.
Detection of hCG concentrations of 25 mIU/ml and greater.
No cross-reactivity with hLH (300mUVml), hFSH (1000 mIU/ml), and hTSH (1000uIU/ml).
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
"Summary of Safety & Effectiveness"
ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for 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 and form a colored line in the Test Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.
A multi-center clinical evaluation was conducted comparing the results obtained using ACON™ hCG One Step Pregnancy Test Device (Urine) and another commercially available urine membrane test. The study included 159 urine specimens tested with both assays. The following results were found:
| | Positive
Results | Negative
Results |
|------------------------------------------------------|---------------------|---------------------|
| ACON™ hCG One Step
Commercially
Available Test | 71 | 88 |
| | 71 | 88 |
ACON™ hCG One Step Pregnancy Test Device (Urine) showed a 100% concordance with the other commercially available test.
ACON™ hCG One Step Pregnancy Test Device (Urine) detects hCG concentrations of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard. The addition of hLH (300mUVml, hFSH (1000 mIU/ml), and hTSH (1000uIU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.
Ara C.R. York
Nora C.R. York ACON Laboratories, Inc. 11175 Flintkote, Avenue, Suite F San Diego. CA 92121 UDA
10/1/99
Date
Premarket Notification 510(k) Number
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 1 1999
Ms. Nora C.R. York Regulatory Affairs Manager Acon Laboratories, Inc. 11175 Flintkote Avenue Suite F San Diego, California 92121
Re: K993317
Trade Name: Acon™ hCG One Step Pregnancy Test Device (Urine) Regulatory Class: II Product Code: JHI Dated: October 1, 1999 Received: October 4, 1999
Dear Ms. York:
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
3
Indications For Use
510(k)Number:_________________________________________________________________________________________________________________________________________________________________
Device Name: ACON™ hCG One Step Pregnancy Test Device (Urine)
"Indications For Use" - ACON™ hCG One Step Pregnancy Test Device (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy. This test is for professional use.
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻟﺴﻴ Prescription Use_
(per 21 CFR 801.109)
Or
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________