(102 days)
The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCULLECT i2000gg System when used for the quantitative determination of cardiac Troponin-1 in human serum and plasma. Refer to the ARCHITECT STAT Troponin-1 reagent package insert for additional information.
ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H
1. Acceptance Criteria and Reported Device Performance:
This document is a 510(k) clearance letter for a quality control material, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, the concept of "acceptance criteria" for a diagnostic accuracy study and "reported device performance" are not directly applicable in the same way they would be for a screening or diagnostic tool.
For this specific device (ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control), the primary acceptance criterion for its 510(k) clearance is substantial equivalence to a legally marketed predicate device. This means the FDA has determined that the new device is as safe and effective as a similar device already on the market.
While not explicitly stated in the provided text as "acceptance criteria" and "reported performance" in a quantitative table for a diagnostic study, the core function of a quality control material is to verify the accuracy and precision of an assay. The premarket notification would have included data demonstrating that this control material performs as expected in validating the ARCHITECT i2000sr System for Troponin-I measurements. This would typically involve:
- Stability data: Showing the control material maintains its specified concentration levels over its shelf life and under various storage conditions.
- Lot-to-lot consistency: Demonstrating that different manufacturing lots of the control material produce consistent results.
- Assigned values and expected ranges: The control material would have known target values for Troponin I that it should register within a specified range when run on the ARCHITECT i2000sr System.
2. Sample Size Used for the Test Set and Data Provenance:
This document is a regulatory clearance letter and does not contain details about specific test set sample sizes or data provenance. For a quality control material, the "test set" would be the internal validation studies conducted by the manufacturer to demonstrate the material's properties (stability, lot consistency, assigned values). Details like sample size, country of origin, and retrospective/prospective nature of these internal studies are not part of the 510(k) clearance letter's publicly available information.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As a quality control material, the "ground truth" is established by the manufacturer through rigorous analytical testing and assignment of target values for the constituents within the control. This is not a human-interpreted diagnostic task requiring expert consensus on images or clinical cases.
4. Adjudication Method for the Test Set:
Not applicable. There is no human interpretation or diagnostic decision-making involved requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. MRMC studies are used to evaluate the impact of a diagnostic device (often image-based AI) on human reader performance. This device is a quality control material, not a diagnostic tool that directly aids human readers in interpretation.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a quality control material, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. Type of Ground Truth Used:
The ground truth for a quality control material is established through analytical testing and assigned values by the manufacturer. This involves precise laboratory measurements using validated reference methods to determine the concentration of the analyte (Troponin I in this case) within the control material. There is often an expected range of values the control should fall within when run on the target instrument.
8. Sample Size for the Training Set:
Not applicable. This device is a quality control material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. See point 8.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized human figure embracing a globe, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The emblem is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 6 2004
Ms. Mary Thorsness Compliance Specialist Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, California 93012
K041194 Re:
K041174
Trade/Device Name: ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: I Product Code: JJX Dated: August 10, 2004 Received: August 11, 2004
Dear Ms. Thorsness:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, the eccordance 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 r ou may, therefore, maine of the Act include requirements for annual registration, listing of general controll provisioning 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 rr your device is elabance a controls. Existing major regulations affecting your device can may oe subject to basil as begulations (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 i rease be actived a determination that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I eather and 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) This letter will anow you'ls begin in the of substantial equivalence of your device to a legally prematics hourication: "The PDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of on questions on the promotion and Safety at (301) 594-3084. Also, please note the In in to Draghostic Do Hoo British by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain other geturers, 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,
Jean M. Cooper, U.S. D.V.M.
Jean M. Cooper, MS, 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
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INDICATIONS FOR USE
510(k) Number (if known): KD4 1194
Device Name:
ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H
Indications for Use:
The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCULLECT i2000gg System when used for the quantitative determination of cardiac Troponin-1 in human serum and plasma. Refer to the ARCHITECT STAT Troponin-1 reagent package insert for additional information.
Prescription Usc (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BULOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Carol Bensen
Division Sign-Off
e of In Vitro Digar
51000 K041194
Page _1_oli_1
§ 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.