(34 days)
Architect CEA MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System.
Architect CEA MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers. Architect CEA MasterCheck Levels 1, 2, 3 and 4 contain CEA (human) prepared in HEPES buffer with protein (bovine) stabilizers. Preservative: Antimicrobial Agent.
The provided text describes the "Architect CEA MasterCheck" device, which is intended for verifying the sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System. However, this document is a 510(k) summary for a control product, not a diagnostic device that outputs performance metrics like sensitivity or specificity based on patient data. Therefore, the typical "acceptance criteria" and "study" framework for a medical device that analyzes patient data to produce a diagnosis or risk assessment does not directly apply here.
Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device (Casco Standards Document Serum Multi-Analyte Verification Test Set) for its intended use as a quality control material. The "performance" described relates to its characteristics as a control, not its diagnostic accuracy in patient samples.
Given this context, I will adapt the request to what can be extracted from the document regarding the characteristics and comparison of the control device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a control product for assay verification and not a diagnostic device, there are no "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC based on patient outcomes. Instead, the "performance" described is in terms of its formulation, intended use, and comparison to a predicate device. The primary "acceptance criteria" for 510(k) clearance in this context are demonstrating substantial equivalence.
| Feature / Criterion | Architect CEA MasterCheck (This Device) | Casco Standards Document Serum Multi-Analyte Verification Test Set (Predicate Device) |
|---|---|---|
| Intended Use | Verification of sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System. | In vitro diagnostic use in the quantitative determination of linearity, calibration verification, and verification of reportable range using automated, semi-automated, and manual methods. |
| Form | Liquid | Liquid |
| Matrix | HEPES buffer with protein (bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | CEA | Multiple |
| Open Vial Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the Architect CEA assay. (More specific to one assay and analyte, different matrix and stability from predicate.) | Calibration verifier for multiple analytes. |
Study to Prove Device Meets Acceptance Criteria (Substantial Equivalence):
The document does not describe a clinical study of the Architect CEA MasterCheck's performance in diagnosing patients. Instead, the "study" implied is the submission of information to the FDA to demonstrate substantial equivalence to a previously cleared device. This involves comparing the technological characteristics of the new device to the predicate device and asserting that any differences do not raise new questions of safety or effectiveness.
The explicit evidence presented in the document to support this claim is the comparison table above. The manufacturer has provided documentation (the 510(k) submission) that details these comparisons, and the FDA has reviewed this information to make a substantial equivalence determination.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the traditional sense of patient samples for diagnostic performance. The "test set" here refers to the device itself and its formulation. The document does not describe a "test set" of patient samples or data.
- Data Provenance: Not applicable. The data being presented is a comparison of product characteristics, not data derived from patient populations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. There is no "ground truth" to establish for a medical device as one would for diagnostic imaging or pathology. The "ground truth" for a control product is its verified formulation and stability, which would be established internally by the manufacturer's quality control and analytical chemistry experts, rather than clinical experts.
4. Adjudication Method for the Test Set:
- Not applicable. There is no expert adjudication process described for the assessment of this control product's characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, like imaging) to compare human reader performance with and without AI assistance. The Architect CEA MasterCheck is a quality control material, not a diagnostic device for patient data interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
- No, a standalone performance study was not done. This device is a biochemical reagent/control, not an algorithm. Its "performance" is in its chemical stability and ability to verify an assay's performance, not in classifying data.
7. The Type of Ground Truth Used:
- For the device itself, the "ground truth" for its characteristics (e.g., CEA concentration, pH, stability) would be established through analytical chemistry techniques and internal validation studies to confirm its formulation and performance as a control material. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical control product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As noted above, there is no training set for this type of device.
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K 940608
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Bio-Rad Laboratories
500 Jeronimo F vine California 92618-20 elephone: (949) 598-12
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation February 23, 1999
Device (Trade & Common Name) Architect CEA MasterCheck
Classification Name Class 1, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Document Serum Multi-Analyte Verification Test Set
Casco Standards Yarmouth, ME K950469
Statement of Intended Use
Architect CEA MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the CEA assay on the Abbott Architect i System.
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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect CEA MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect CEA MasterCheck Levels 1, 2, 3 and 4 contain CEA (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Architect CEA MasterCheck and the devices to which substantial equivalence is claimed.
| Architect CEA MasterCheck | Casco Standards DocumentSerum Multi-AnalyteVerification Test Set | |
|---|---|---|
| IntendedUse | Verification of sensitivity,calibration linearity, andreportable range of theCEA assay on the AbbottArchitect i System. | In vitro diagnostic use in thequantitative determination oflinearity, calibrationverification and verificationof reportable range usingautomated, semi-automatedand manual methods. |
| Form | Liquid | Liquid |
| Matrix | HEPES buffer with protein(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | CEA | Multiple |
| Open VialClaim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for theArchitect CEA assay. | Calibration verifier formultiple analytes. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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MAR 300 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re: K990608 Trade Name: Architect™ CEA MasterCheck Regulatory Class: I Product Code: JJX Dated: February 23, 1999 Received: February 24, 1999
Dear Ms. Platt:
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 (QS) 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 Putman
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
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Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Architect CEA MasterCheck
Indications for Use:
Architect CEA MasterCheck is intended for use in the verification of Arenitoot OEA Mactor Should Shourity, and reportable range of the CEA assay on the Abbott Architect i System.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990608 |
| Prescription Use | OR Over-The Counter Use | |
|---|---|---|
| ------------------ | ---------------------------------------------- | ------------------------- |
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.