(64 days)
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.
The Access Total BhCG assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffer.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that "proves" the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in a quantitative or qualitative manner. Instead, the entire submission hinges on demonstrating "substantial equivalence" to a previously cleared device. Therefore, the "reported device performance" is framed in terms of this equivalence, rather than meeting predefined performance metrics.
However, based on the study performed, we can infer the implicit acceptance criterion was "good correlation" between plasma and serum samples.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| "Good correlation" between plasma and serum samples | "Study results demonstrate good correlation between the plasma and serum samples." |
| Substantial equivalence to predicate device (K980173) | "The Access Total BhCG assay is substantially equivalent to the previously cleared Access Total BhCG assay (K980173)." |
| Same methodology, product type, and quantitative results as predicate device | "Both assays utilize the same methodology, are the same product type, and are quantitative." |
| Including same components as predicate device | "The subject and predicate assays include the same components." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text states, "a method correlation study, using paired plasma and serum samples, was conducted." However, the exact number of paired samples is not provided.
- Data Provenance: The text does not specify the country of origin. The study was a "method correlation study," which implies it was conducted specifically to support this submission. It is prospective in the sense that the data was generated for the purpose of demonstrating equivalence, and likely involved fresh samples run on the new and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth in this submission. This type of device (quantitative immunoassay for hCG) typically relies on direct measurement and comparison with a reference method or predicate device, rather than expert interpretation of results. The "ground truth" here is the value obtained by the predicate device and the correlation between different sample types.
4. Adjudication Method for the Test Set
No adjudication method is described or implied. As mentioned above, the "ground truth" is based on direct measurement and comparison, not on expert consensus that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices where human readers (e.g., radiologists) are involved in assessing images or other complex data, often with and without AI assistance. This submission describes a quantitative in-vitro diagnostic (IVD) assay where the device provides a numerical result, not an interpretation requiring human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an IVD assay, not an algorithm in the typical sense of AI/ML. The "device performance" described for the Access Total BhCG assay is inherently what would be considered "standalone" clinical performance. It measures hCG levels directly. There is no human "in-the-loop" for the interpretation of the raw quantitative output of the assay, though a clinician would interpret the hCG level in the context of a patient's overall health.
7. The Type of Ground Truth Used
The ground truth used for this study is essentially analytical performance against a legally marketed predicate device (Access Total BhCG assay, K980173) and consistency across different sample matrices (serum vs. plasma). The "truth" for the new device is its ability to produce results that correlate well with the established method and to demonstrate similar performance characteristics.
8. The Sample Size for the Training Set
No training set is described. This context is for a traditional IVD assay, not an AI/ML-based device that would typically involve a distinct training (and validation/test) set. The "supporting data" section focuses on the test set (paired plasma and serum samples) for demonstrating equivalence.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for this specific device, this question is not applicable.
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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 - DiagnosticsDivision1000 Lake Hazeltine DriveChaska, MN 55318 | Denise ThompsonRegulatory Affairs SpecialistPhone: 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 CFR862.1155) |
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.
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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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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
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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
§ 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.