(23 days)
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No
The document describes a quality control material for immunoassay systems and does not mention any AI or ML components.
No
The device is described as a quality control material for immunoassays, not a device used for treating disease.
No
This device is a quality control material used to monitor the accuracy and precision of immunoassay systems, not to diagnose medical conditions in patients. It's used to check the performance of other diagnostic devices.
No
The device description clearly states it is a "bilevel lyophilized preparation of pooled human sera," 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 "quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems." Immunoassays are laboratory tests performed in vitro (outside the body) to measure substances in biological samples. Quality control materials are essential for ensuring the accuracy and reliability of these in vitro tests.
- Device Description: The description mentions it's a "lyophilized preparation of pooled human sera containing CK-MB, Digoxin, Myoglobin, and NT-proBNP for monitoring accuracy and precision on Elecsys immunoassay analyzers." This further confirms its use in a laboratory setting to evaluate the performance of in vitro diagnostic tests.
The purpose of this device is to assess the performance of other IVD tests, making it an IVD itself.
N/A
Intended Use / Indications for Use
PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Roche Diagnostics Elecsys® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB, Digoxin, Myoglobin, and NT-proBNP for monitoring accuracy and precision on Elecsys immunoassay 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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§ 862.1660 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.
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510(k) Summary - Elecsys® PreciControl Cardiac K032089
| 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: July 2, 2003 |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® PreciControl Cardiac
Common name: Elecsys® PreciControl Cardiac
Classification name: Multi-analyte Controls (assayed and unassayed) |
| Device
description | Roche Diagnostics Elecsys® PreciControl Cardiac is a bilevel lyophilized
preparation of pooled human sera containing CK-MB, Digoxin, Myoglobin,
and NT-proBNP for monitoring accuracy and precision on Elecsys
immunoassay analyzers. |
| Intended use | PreciControl Cardiac is used for quality control of the Elecsys CK-MB,
Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys
immunoassay systems. |
| Predicate
Device | We claim substantial equivalence to the currently marketed Elecsys®
PreciControl Cardiac. (K983492). |
1
510(k) Summary - COBAS Integra Creatinine plus ver.2, continued
continued
. r
Reagent Summary The following table describes the similarities and differences between the Elecsys® PreciControl Cardiac and the predicate device.
| Topic | Elecsys® PreciControl Cardiac
(K983492) | Elecsys® PreciControl Cardiac
(Modified Device) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl Cardiac is used for
quality control of the Elecsys CK-
MB, Myoglobin and Troponin T
(CARDIAC T) immunoassays on
Elecsys immunoassay systems. | PreciControl Cardiac is used for
quality control of the Elecsys-CK-
MB, Digoxin, Myoglobin, and NT-
proBNP immunoassays on the
Elecsys immunoassay systems. |
| Analyzer
System | Elecsys® immunoassay analyzers | Same |
| Reagent
Format | lyophilized, based on human serum | Same |
| Analyte
Concentration
PC CARD 1 | CK-MB: approximately 5 ng/ml
Myoglobin: approximately 80 ng/ml
Troponin T: approximately 0.15
ng/ml | CK-MB: Same
Myoglobin: Same
Digoxin: approximately 1.2 ng/ml
NT-proBNP: approximately 0.15
ng/ml |
| Analyte
Concentration
PC CARD 2 | CK-MB: approximately 50 ng/ml
Myoglobin: approximately 1000
ng/ml
Troponin T: approximately 5 ng/ml | CK-MB: Same
Myoglobin: Same
Digoxin: approximately 3 ng/ml
NT-proBNP: approximately 5 ng/ml |
| Stability | 3 hrs at 20 - 25° C
3 days at 2 - 8° C
3 months at -20° C (only freeze once) | Same |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
JUL 3 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K032089
Trade/Device Name: Elecsys® PreciControl Cardiac Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 2, 2003 Received: July 7, 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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Page 2 -
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 Sutman
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 Ko 3 2 0 8 9
Device Name: Elecsys® PreciControl Cardiac
Indications For Use:
PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032089
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _________________ (Per 21 CFR 801.109)
(Optional Format 1-2-96)