(102 days)
Not Found
ARCULLECT i2000gg System
No
The document describes a control material for a laboratory assay system and does not mention any AI or ML components.
No
The device is a control used for verifying the accuracy and precision of an analytical system for determining cardiac Troponin-1, not for treating any condition.
No
The device description indicates control materials ("ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H") used for verifying accuracy and precision of a system that measures cardiac Troponin-1. Control materials are used in diagnostic tests but are not diagnostic devices themselves; they ensure the diagnostic system is working correctly.
No
The device description clearly states "ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H," indicating a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are for "verification of the accuracy and precision of the ARCHITECT i2000sr System when used for the quantitative determination of cardiac Troponin-I in human serum and plasma." This involves testing biological samples (serum and plasma) in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The device is described as "ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H". Controls are a standard component of IVD testing, used to ensure the reliability and accuracy of the diagnostic assay.
- Context: The controls are used with the ARCHITECT i2000sr System, which is a platform for performing diagnostic tests on biological samples.
Therefore, based on the provided information, the ARCHITECT Troponin-I Controls are clearly intended for use in an in vitro diagnostic process.
N/A
Intended Use / 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.
Product codes
JJX
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Key Metrics
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
2
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
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