(14 days)
Not Found
No
The document describes a quality control material for laboratory tests and does not mention any AI or ML components.
No
This device is a quality control material intended to monitor the accuracy and precision of quantitative methods in laboratory testing, not to treat or diagnose patients.
No
Explanation: The device is described as a quality control material used to monitor accuracy and precision of quantitative methods in Roche test systems, not to diagnose a disease or condition in a patient.
No
The device description clearly states that the device is a lyophilized control material based on bovine serum albumin with biological additives. This indicates a physical, chemical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the devices are "for use in quality control by monitoring accuracy and precision for the quantitative methods" and are "intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations". This clearly indicates their use in a laboratory setting to evaluate the performance of diagnostic tests.
- Device Description: The description details the composition of the controls (lyophilized controls based on bovine serum albumin with biological additives) and their purpose in quality control.
- Predicate Device: The mention of a predicate device (K003158; Precinorm CK-MB control) which is also a control material used in diagnostic testing further supports its classification as an IVD.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Quality control materials like Precinorm CK-MB and Precipath CK-MB are essential components of IVD systems, ensuring the reliability and accuracy of diagnostic test results.
N/A
Intended Use / Indications for Use
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Precinorm CK-MB and Precipath CK-MB are assayed quality control material intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precinorm CK-MB is a lyophilized controls based on bovine serum albumin. Adjusted activities of the control components are usually in the normal range or at the normal/pathological threshold. Precipath CK-MB is a lyophilized controls based on bovine serum albumin. Adjusted activities of the control components are usually in the pathological range. Biological additives for both control levels include CK-MM from human origin and CK-BB from porcine brain.
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
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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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K062972
OCT 13 2006
510(k) Summary–Precinorm CK-MB & Precipath CK-MB
| Introduction | Roche Diagnostics Corporation hereby submits this Special 510(k): Device
Modification to provide notification of modifications to our Precinorm CK-
MB Control. This control was originally cleared for use in K003158, along
with a CK-MB reagent and calibrator system on Roche/Hitachi Analyzers. | | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Modifications to the control include: | | |
| | Change of name for Precinorm CK-MB to Precipath CK-MB (no
change of analyte concentration), andNew, additional control level with reduced levels of CK and CK-MB
to normal levels. This new level is now called Precinorm CK-MB. | | |
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd
Indianapolis IN 46250
(317) 521-7637
Contact person: Kerwin Kaufman
Date prepared: September 28, 2006 | | |
| Device Name | Proprietary name: Precinorm CK-MB and Precipath CK-MB Controls
Common name: Single (Specified) Analyte Controls (assayed and unassayed)
Classification name: Quality control material (assayed and unassayed) | | |
| Device
Description | Precinorm CK-MB is for use in quality control by monitoring accuracy and
precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and
precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm CK-MB is a lyophilized controls based on bovine serum albumin.
Adjusted activities of the control components are usually in the normal range
or at the normal/pathological threshold. Precipath CK-MB is a lyophilized
controls based on bovine serum albumin. Adjusted activities of the control
components are usually in the pathological range. Biological additives for
both control levels include CK-MM from human origin and CK-BB from
porcine brain. | | |
| Intended use | Precinorm CK-MB is for use in quality control by monitoring accuracy and
precision for the quantitative methods as specified in the enclosed value sheet. | | |
| | Precipath CK-MB is for use in quality control by monitoring accuracy and
precision for the quantitative methods as specified in the enclosed value sheet. | | |
| Predicate | We claim substantial equivalence to the Precinorm CK-MB control cleared in | | |
| Device | K003158. | | |
| Substantial | The table below indicates the similarities and differences between the | | |
| equivalency - | modified Precinorm CK-MB control and its predicate device (Precinorm CK- | | |
| Similarities/Diff | MB, K003158). Note that the predicate device is now sold as Precipath CK- | | |
| erences | MB (no change in analyte concentration) as described above. | | |
.
Continued on next page
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510(k) Summary–Precinorm CK-MB & Precipath CK-MB,
Continued
| Feature | Predicate device:
Precinorm CK-MB
(K003158) | Modified device:
Precinorm CK-MB and
Precipath CK-MB |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
(from labeling) | Precinorm CK-MB is for use in the
quality control of Roche methods for
the quantitative determination of
CK-MB and creatine kinase
activities. The control is used for
monitoring accuracy and precision
both for manual techniques and for
assays on clinical chemistry
analyzers. | Precinorm CK-MB is for use in
quality control by monitoring
accuracy and precision for the
quantitative methods as specified in
the enclosed value sheet.
Precipath CK-MB is for use in
quality control by monitoring
accuracy and precision for the
quantitative methods as specified in
the enclosed value sheet. |
| Reagent
composition | Lyophilized control serum based on
bovine serum albumin with
chemical additives and material of
biological origin. | Same |
Continued on next page
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510(k) Summary–Precinorm CK-MB & Precipath CK-MB, Continued
| Feature | Predicate device:
Precinorm CK-MB
(K003158) | Modified device:
Precinorm CK-MB and
Precipath CK-MB |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Active
Ingredient Level | Precinorm CK-MB:
CK and CK-MB usually at
pathological level | Precinorm CK-MB:
CK and CK-MB usually at normal
range or at the normal/pathological
threshold.
Precipath CK-MB:
CK and CK-MB usually at
pathological level |
| Stability - shelf
life and open vial | 2-8 °C until expiration date
Reconstituted:
24 hours at 25° C
3 days at 4° C
1 month at -20° C (freeze only once) | Same |
| Traceability | Traceability of the target values is
given in the respective instructions
for use of the system reagent to be
used in combination with the
recommended calibrator. | Same |
| Value
Assignment | The value assignment takes place in
three internal laboratories. Each
laboratory runs at least three
independent series. An independent
series includes full calibration using
a new calibrator vial and sample
vial. The mean is used as setpoint.
Controls which have to be assigned
are used as samples. The master
calibrator is used for calibration. | Same |
Substantial equivalency – Similarities/Differences (continued)
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 3 2006
Mr. Kerwin Kaufman Roche Diagnostics PO Box 50457 9115 Hague Rd Indianapolis, IN 46250
Re:
K062972 Trade/Device Name: Precinorm CK-MB and Precipath CK-MB Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: September 28, 2006 Received: September 29, 2006
Dear Mr. Kaufman:
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 revire 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 aft 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez
Alberto Gutierrez, Ph.D. 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):
Device Name: Precinorm CK-MB and Precipath CK-MB Controls
Indications For Use:
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Precinorm CK-MB and Precipath CK-MB are assayed quality control material intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K062972