(64 days)
Not Found
No
The summary describes a quantitative immunoassay for βhCG levels, which is a standard laboratory test and does not mention any AI/ML components or image processing.
No.
The device is an in vitro diagnostic assay used for quantitative determination of total βhCG levels in human serum and plasma to detect early pregnancy. It does not directly treat or prevent a disease or condition.
Yes
The device is described as providing "in vitro quantitative determination of total βhCG levels in human serum and plasma," which is a diagnostic measurement. It is also "indicated for use with patients where an early detection of pregnancy status is desired," fulfilling a diagnostic purpose.
No
The device description explicitly states it consists of a reagent pack and calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay provides "in vitro quantitative determination of total βhCG levels in human serum and plasma." The term "in vitro" is a key indicator of an IVD, meaning it's used to test samples taken from the body, rather than directly on the body.
- Sample Type: The assay is designed to test "human serum and plasma," which are biological samples taken from a patient.
- Purpose: The purpose is to determine "total βhCG levels," which is a common diagnostic test performed on biological samples to assess pregnancy status.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access Total βhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total βhCG assay is indicated for use with patients where an early detection of pregnancy status is desired.
Product codes
JHI, JIT
Device Description
The Access Total BhCG assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence, a method correlation study, using paired plasma and serum samples, was conducted using the Access Total βhCG assay. Study results demonstrate good correlation between the plasma and serum samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
[As required by 21 CFR 807.92]
510(k) Number QQA3480
Date Prepared: 10/16/2002
| Submitter | Contact Person |
|---|---|
| Beckman Coulter, Inc - Diagnostics | |
| Division | |
| 1000 Lake Hazeltine Drive | |
| Chaska, MN 55318 | Denise Thompson |
| Regulatory Affairs Specialist | |
| Phone: 952-368-1202; Fax: 952-368-7610 |
General Information
| Trade Name | Access® Total βhCG |
|---|---|
| Common Name | Human chorionic gonadotropin |
| Classification Name | Human chorionic gonadotropin (HCG) test system (21 CFR |
| 862.1155) |
Device Description
The Access Total BhCG assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffer.
Intended Use
The Access® Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total ßhCG levels in human serum and plasma using the Access Immunoassay Systems.
Substantial Equivalence Comparison
The Access Total ßhCG assay is substantially equivalent to the previously cleared Access Total BhCG assay (K980173). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays include the same components. The only difference between the two assays is that the sample type has been expanded to include human plasma samples.
Supporting Data
To demonstrate substantial equivalence, a method correlation study, using paired plasma and serum samples, was conducted using the Access Total βhCG assay. Study results demonstrate good correlation between the plasma and serum samples.
Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Access Total BhCG assay.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Denise Thompson Regulatory Affairs Specialist . Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re:
K023480 -Trade/Device Name: Access® Total BhCG on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI; JIT Dated: October 16, 2002 Received: October 17, 2002
Dear Ms. Thompson:
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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Page 2 -
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications Statement
Page 1 of 1
510(k) Number: K023480
Device Name: Access® Total βhCG on the Access® Immunoassay Systems
Indications:
The Access Total βhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total βhCG assay is indicated for use with patients where an early detection of pregnancy status is desired.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
prescription use
Alan Cooper
of Clinical Laborate