(25 days)
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No
The device description and performance studies describe a traditional immunoassay based on antibody reactions and visual interpretation of colored lines. There is no mention of AI, ML, image processing, or any computational analysis of the results.
No
The device is intended for the rapid qualitative identification of hCG to aid in the early determination of pregnancy, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the rapid qualitative identification of hCG in serum or urine to aid in the early determination of pregnancy, which is a diagnostic purpose.
No
The device description clearly outlines a physical test device that utilizes antibodies and capillary action on a membrane to detect hCG, indicating it is a hardware-based diagnostic test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy." This describes a test performed on biological specimens (serum or urine) outside of the body to provide information about a physiological state (pregnancy).
- Device Description: The description details how the test works by reacting with components in the specimen (hCG) to produce a result (colored lines). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes clinical evaluations using serum and urine specimens to assess the device's performance against another commercially available test. This type of testing is standard for IVDs.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. The Acon™ Combo Pregnancy test fits this definition perfectly.
N/A
Intended Use / Indications for Use
Acon™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.
Product codes (comma separated list FDA assigned to the subject device)
JHI
Device Description
Acon™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination 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 Specimen 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. Acon™ Combo Pregnancy 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 hI.H (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.
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 Acon™ Combo Pregnancy and another commercially available serum/urine membrane test. The study included 159 urine and 73 serum specimens tested with both assays. Urine specimens: 71 positive results and 88 negative results for both Acon™ Combo and the Commercially Available Test. Serum specimens: 21 positive results, 51 negative results, and 1 inconclusive result for both Acon™ Combo and the Commercially Available Test.
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™ Combo Pregnancy and another commercially available serum/urine membrane test. The study included 159 urine and 73 serum specimens tested with both assays. Acon™ Combo Pregnancy showed a 100% concordance with the other commercially available test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination 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 Specimen 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™ Combo Pregnancy and another commercially available serum/urine membrane test. The study included 159 urine and 73 serum specimens tested with both assays. The following results were found:
| | Positive
Urine Results | Negative
Urine Results | |
|--------------------------------|---------------------------|---------------------------|-------------------------------|
| Acon™ Combo | 71 | 88 | |
| Commercially
Available Test | 71 | 88 | |
| | Positive
Serum Results | Negative
Serum Results | Inconclusive
Serum Results |
| Acon™ Combo | 21 | 51 | 1 |
| Commercially
Available Test | 21 | 51 | 1 |
Acon™ Combo Pregnancy showed a 100% concordance with the other commercially available test.
Acon™ Combo Pregnancy 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 hI.H (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative and positive serum and urine specimens showed no cross-reactivity.
Tian Lin
9-10-1999
Date
Jixun Lin. M.D., Ph.D. Acon Laboratories, Inc. 11175 Flintkote Avenue, Suite F San Diego, CA 92121 USA
K99.3065
Prema ket Notification 510(k) Number
Page 1 of 18
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the flow of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is in black and white.
OCT 8 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jixun Lin, M.D., Ph.D. President Acon Laboratories, Inc. 11175 Flintkote Avenue Suite F San Diego, California 92121
Re: K993065
· Trade Name: Acon™ Combo Pregnancy Regulatory Class: II Product Code: JHI Dated: September 9, 1999 Received: September 13, 1999
Dear Dr. Lin:
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 (OS) 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 Sutman
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: K993065
Device Name: Acon™ Combo Pregnancy
"Indications For Use" -
Acon™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.
Jean Cooper
(Division Sign-Off) Division of Clinical Laboratory L evices 1 993065 510(k) Number _
(Please do not write below this point)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
or
Over-The-Counter Use