(15 days)
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No
The document describes a calibrator for clinical chemistry analyzers, which is a standard laboratory reagent. There is no mention of AI or ML in the intended use, device description, or any other section. The predicate device is also a calibrator, further indicating a non-AI/ML technology.
No.
The device is a calibrator for analytical systems, used to ensure the accurate measurement of quantitative methods on clinical chemistry analyzers, not directly for treating patients.
No
This device is a calibrator for automated systems used in the calibration of quantitative Roche methods on clinical chemistry analyzers, not a diagnostic device itself.
No
The device description explicitly states it is a lyophilized human serum calibrator, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration of quantitative Roche methods on Roche clinical chemistry analyzers." Clinical chemistry analyzers are used to perform in vitro diagnostic tests on biological samples (like serum). Calibration is a crucial step in ensuring the accuracy of these tests.
- Device Description: It is a "lyophilized human serum calibrator." Human serum is a biological sample, and calibrators are used in the process of performing diagnostic tests on such samples.
- Predicate Device: The mention of a predicate device (K990460; Calibrator for Automated Systems (C.f.a.s.)) further confirms its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and in the context of medical devices, this often points to a similar regulatory classification, which for calibrators used in clinical chemistry is typically IVD.
Therefore, based on the provided information, the Calibrator for Automated Systems (C.f.a.s.) is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
NOV 2 0 2003
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K033501' and are written in black ink on a white background. The handwriting is somewhat stylized, but the characters are still legible.
510(k) Summary - Calibrator for Automated Systems (C.f.a.s.)
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831
Contact person: Sherri L. Coenen
Date prepared: November 3, 2003 |
| Device Name | Proprietary name: Calibrator for Automated Systems (C.f.a.s.)
Common name: Calibrator for Automated Systems (C.f.a.s.)
Classification name: Calibrator, Multi-analyte mixture |
| Device
description | The Calibrator for Automated Systems (C.f.a.s.) is a lyophilized human serum
calibrator with chemical additives and materials of biological origin. The
concentration of the calibrator components have been adjusted to ensure
optimal calibration of the appropriate Roche methods on clinical chemistry
analyzers. |
1
510(k) Summary - Calibrator for Automated Systems
(C.f.a.S.), continued
Intended use Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. の 2006年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 We claim substantial equivalence to the currently marketed Calibrator for Predicate Device Automated Systems (C.f.a.s.)(K990460).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 0 2003
Ms. Sherri L. Coenen Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K033501
Trade/Device Name: Calibrator for Automated Systems (C.f.a.s.) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 3, 2003 Received: November 5, 2003
Dear Ms. Coenen:
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). You may obtain other general information on your responsibilities under the Act 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 Butman
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
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Calibrator for Automated Systems (C.f.a.s.)
Indications For Use:
Calibrator for automated systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Alberto Cuté
Division Sign-Off for Team Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033501