(63 days)
Abbott ARCHITECT™ Total ß-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of betahuman chorionic gonadotropin (ß-hCG) in human serum and plasma on the Abbott ARCHITECT i System for the early detection of pregnancy.
ARCHITECT Total 3-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of ß-hCG in human serum and plasma (lithium heparin, sodium heparin, or potassium EDTA) for the early detection of pregnancy. ARCHITECT Total B-hCG is calibrated with ARCHITECT Total B-hCG Calibrators. ARCHITECT Total {}-hCG Controls are assayed to verify the accuracy and precision of the Abbott ARCHITECT i System.
Here's an analysis of the provided text regarding the Abbott ARCHITECT™ Total ß-hCG device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Quantitative Correlation with Predicate Device (AxSYM® Total ß-hCG assay) | |
| Correlation Coefficient | 0.987 (Least Squares & Passing-Bablok) |
| Slope (Least Squares Regression) | 0.82 (95% CI: 0.81 to 0.84) |
| Y-axis Intercept (Least Squares Regression) | 58.29 mIU/mL (95% CI: -11.67 to 128.26) |
| Slope (Passing-Bablok Regression) | 0.88 mIU/mL (95% CI: 0.86 to 0.90) |
| Y-axis Intercept (Passing-Bablok Regression) | 4.36 mIU/mL (95% CI: 2.47 to 7.06) |
| Qualitative Agreement (Implied for early detection of pregnancy) | Not explicitly stated but implied by substantial equivalence claim. |
Study Proving Device Meets Acceptance Criteria
The study conducted to demonstrate the safety and effectiveness, and thus substantial equivalence, of the ARCHITECT Total ß-hCG assay involved a direct comparison with a legally marketed predicate device, the AxSYM® Total ß-hCG assay.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 337 specimens
- Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the study was retrospective or prospective. Given the nature of a 510(k) submission, it's typically retrospective analysis of existing clinical samples or prospectively collected samples for method comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For an immunoassay, the "ground truth" for the test set is typically the result obtained from the predicate device (AxSYM® Total ß-hCG assay) or a reference method. It does not involve human expert consensus in the same way as an imaging device might.
4. Adjudication Method for the Test Set
This information is not applicable in the context of this type of immunoassay comparison study. Adjudication methods like 2+1 or 3+1 are typically used for interpreting subjective data (e.g., medical images) where human readers disagree. For quantitative laboratory tests, the comparison is directly between the numerical results of the candidate and predicate assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging devices, pathology slides) and would measure the improvement in human reader performance with AI assistance. The ARCHITECT Total ß-hCG is an automated immunoassay, not one requiring human interpretation of complex visual data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study described is essentially a standalone performance study of the ARCHITECT Total ß-hCG assay. It assesses the algorithm's (the assay's) performance in determining ß-hCG levels and compares it to a predicate device, without human intervention in the result determination process itself. The "human-in-the-loop" aspect for such a device would typically be limited to the lab technician running the assay and interpreting the final numerical results against clinical cutoffs, which is not what an MRMC study assesses.
7. The Type of Ground Truth Used
The ground truth for the comparison was the results obtained from the predicate device, the AxSYM® Total ß-hCG assay. The AxSYM assay itself would have been validated against a more fundamental reference method or clinical outcomes during its own clearance process.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. For substantial equivalence studies of this nature, the focus is typically on performance against the predicate, using a single set of samples. While the ARCHITECT system itself would have undergone internal development, calibration, and optimization, the data presented here is for the final performance evaluation.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated training set is not explicitly mentioned with its own ground truth establishment in this document, this information is not provided. For a device like this, calibration and optimization (which can be considered akin to "training") would typically involve a proprietary set of samples with known (or precisely measured by a reference method) ß-hCG concentrations.
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510(k) Summary Abbott ARCHITECT™ Total 3-hCG
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT™ Total B-hCG constitutes data supporting a substantially equivalent determination.
ARCHITECT Total 3-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of ß-hCG in human serum and plasma (lithium heparin, sodium heparin, or potassium EDTA) for the early detection of pregnancy. ARCHITECT Total B-hCG is calibrated with ARCHITECT Total B-hCG Calibrators. ARCHITECT Total {}-hCG Controls are assayed to verify the accuracy and precision of the Abbott ARCHITECT i System.
Substantial equivalence has been demonstrated between the ARCHITECT Total B-hCG assay and the AxSYM® Total B-hCG assay. The intended use of both assays is for the quantitative and qualitative determination of beta-human chorionic gonadotropin (18-hCG) for the early detection of pregnancy. Both assays are automated, in vitro immunoassays that use antibodies specific for B-hCG. A least squares linear regression analysis between these two assays, using 337 specimens over a range of 2.0 to 15,000 mIU/mL, yielded a correlation coefficient of 0.987, slope of 0.82 (95% confidence interval [CI] of 0.81 to 0.84), and y-axis intercept of 58.29 mIUmL (95% CI of -11.67 to 128.26). A Passing-Bablok linear regression analysis between these two assays, using 337 specimens over a range of 2.0 to 15,000 mIU/mL, vielded a correlation coefficient of 0.987, slope of 0.88 mIU/mL (95% CI of 0.86 to 0.90), and y-axis intercept of 4.36 mIU/mL (95% CI of 2.47 to 7.06).
In conclusion, these data demonstrate that the ARCHITECT Total B-hCG assay is as safe and effective as, and is substantially equivalent to, the AxSYM Total ß-hCG assay.
Prepared and Submitted September 28, 1998, by: Karen L. Gates, M.S. Sr. Regulatory Specialist ADD Regulatory Affairs 847-938-0538
Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537
ARCHITECT Total ß-hCG 510(k) September 1998
Section II Page 1
11983424
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 1998
Karen L. Gates, M.S. Sr. Regulatory Specialist ADD Requlatory Affairs ABBOTT LABORATORIES 200 Abbott Park Road Abbott Park, IL 60064-3537
Re: K983424 Trade Name: Abbott ARCHITECT™ Total ß-hCG Requlatory Class: II Product Code: 75 DHA November 16, 1998 Dated: Received: November 17, 1998
Dear Ms. Gates:
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 aqainst 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. 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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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 qeneral 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical ·Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known): _ 983434
Device Name: Abbott ARCHITECT™ Total B-hCG
Indications For Use:
Abbott ARCHITECT™ Total ß-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of betahuman chorionic gonadotropin (ß-hCG) in human serum and plasma on the Abbott ARCHITECT i System for the early detection of pregnancy.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K98 3424
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
-Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.