(233 days)
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No
The summary describes a standard immunoassay system and does not mention any AI or ML components.
No
Explanation: This device is an in vitro diagnostic assay used for the quantitative determination of total beta human chorionic gonadotropin levels to detect early pregnancy. It is not designed for therapy or treatment.
Yes
The document states "For in vitro diagnostic use only," indicating its function in diagnosing pregnancy.
No
The device description clearly states it is a "paramagnetic particle, chemiluminescent immunoassay" and is used with the "Olympus AU3000i Immunoassay System," indicating it is a physical assay kit and a hardware system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Nature of the Assay: The description details a "paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin... in human serum." This type of assay is performed on biological samples outside of the body to diagnose or monitor a condition.
- Purpose: The assay is used for the "early detection of pregnancy," which is a diagnostic purpose.
- Components: The system includes a calibrator and control, which are standard components of IVD test systems used to ensure accuracy and quality control.
All of these factors strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Olympus Total BhCG Test System (OS210303).
The Olympus ßhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System. Total BhCG is used for the early detection of pregnancy. For in vitro diagnostic use only.
The Olympus ßhCG Calibrator is for calibrating the quantitative Olympus ßhCG assay on the Olympus AU3000i Immunoassay System.
The Olympus BhCG Control is used for quality control of the Olympus BhCG assay on the Olympus AU3000i Immunoassay System.
Product codes
DHA, JIT, JJX
Device Description
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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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP - 3 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Olympus America Inc. c/o Ms. Stephanie Donnelly Regulatory Affairs/Quality Assurance Manager 3131 West Royal Lane Irving, TX 75063
Re: K080094 Trade/Device Name: Olympus Total BhCG Test System Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin test system Regulatory Class: Class II Product Code: DHA, JIT, JJX Dated: July 23, 2008 Received: July 28, 2008
Dear Ms. Donnelly:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indication for Use
510(k) Number (if known): KOEOO94
Device Name: The Olympus Total BhCG Test System (OS210303).
The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System. Total BhCG is used for the early detection of pregnancy. For in vitro diagnostic use only.
The Olympus ßhCG Calibrator is for calibrating the quantitative Olympus ßhCG assay on the Olympus AU3000i Immunoassay System.
The Olympus BhCG Control is used for quality control of the Olympus BhCG assay on the Olympus AU3000i Immunoassay System.
Prescription Use __ V__ (21 CFR Part 801 Subpart D)
Over the Counter Use
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Q
Division Sign-Off Office of th Vitro Diagnostic Device Evaluation and Safety
510(k) K080094