(169 days)
Not Found
No
The device is a quality control material for laboratory assays and the summary contains no mention of AI or ML.
No.
The device is a quality control material used to monitor the accuracy and precision of quantitative methods, not to treat or diagnose a disease.
No
Explanation: The device is a quality control set used to monitor the accuracy and precision of quantitative methods in laboratory settings, not to diagnose a patient's condition.
No
The device is a control set consisting of lyophilized human serum, 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 "used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description details a "Multi-Analyte Controls, All Kinds (assayed and unassayed)" with a matrix of "Human serum with material of biological origin." Controls are a fundamental component of IVD testing to ensure the reliability of results.
- Classification Name: The classification name "Multi-Analyte Controls, All Kinds (assayed and unassayed) in Class I" is a recognized classification for IVD devices by regulatory bodies like the FDA.
- Handling: The instructions for reconstitution and mixing are typical for IVD reagents and controls.
- Intended User / Care Setting: The description of use in "quantitative methods" and the implication of use in a "laboratory or clinical setting by trained personnel" aligns with the typical environment for IVD testing.
- Summary of Performance Studies: The mention of evaluation studies for "value assignment and stability" are standard performance characteristics assessed for IVD controls.
- Predicate Device(s): The listing of a predicate device with a K number (K040280) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used to demonstrate substantial equivalence to previously cleared IVDs.
All these factors point to this device being an In Vitro Diagnostic product used to ensure the quality and reliability of other diagnostic tests.
N/A
Intended Use / Indications for Use
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Prealbumin/Ceruloplasmin Control Set was evaluated for value assignment and stability. A summary of the evaluation studies is provided in the Performance Characteristics Section of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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
JAN 3 1 2007
510(k) Summary
| Purpose | In accordance with 21 CFR 907.87, Roche Diagnostics hereby submits
official notification as required by Section 510(k) of the Federal Food, Drug
and Cosmetics Act of our intention to market the device described in this
Premarket Notification [510(k)]. | | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------------------------------------|---------------------|
| Device Name | Proprietary name: Prealbumin/Ceruloplasmin Control Set
Common name: Precinorm/Precipath PC
Classification name: Multi-Analyte Controls, All Kinds (assayed and
unassayed) in Class I | | | |
| Establishment registration | The establishment registration number for Roche Diagnostics Penzberg is
9610529. | | | |
| Classification | The FDA has classified Multi-Analyte Controls, All Kinds (assayed and
unassayed) in Class I. | | | |
| | Panel | Classification Number | Classification Name | Regulation Citation |
| | 75 Clinical
Chemistry | JJY | Quality control material
(assayed and unassayed) | 21 CFR 862.1660 |
: 上一篇:
1
| Performance
Standards | To date, no performance standards that affect this device have been finalized
under Section 514 of the Act. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proposed
labeling | Proposed labeling sufficient to describe the device, its intended use, and the
directions for use are attached. We believe the proposed version of the device
labeling presented in Section V contains all of the technical information
required per 21 CFR 809.10. |
| Substantial
equivalence | Prealbumin/Ceruloplasmin Control Set is substantially equivalent to other
products in commercial distribution intended for similar use. We claim
equivalency to the currently marketed Precinorm PUC (K040280). |
| Substantial
equivalence:
Similarities | The below tables compare Prealbumin/Ceruloplasmin Control Set with the
predicate device, Precinorm PUC (K040280). |
| Characteristic | Prealbumin/Ceruloplasmin
Control Set | Predicate Device
Precinorm PUC (K040280). |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Prealbumin/Ceruloplasmin
Control Set
(Precinorm/Precipath PC) is
used for quality control by
monitoring accuracy and
precision for the quantitative
methods as specified in the
enclosed value sheet. | Precinorm PUC (Proteins in
Urine/CSF) is for use in
quality control by monitoring
accuracy and precision for the
quantitative methods as
specified in the enclosed value
sheet. |
| Stability | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• at 15 – 25 °C: up to 8 hrs
• at 2-8°C: 2 days
• at (-15)-(-25)°C: 2 weeks
(freeze only once) | Unopened:
• Store at 2-8°C until
expiration date
Opened:
• Stable for 4 weeks at 2-8°C. |
Continued on next page
·
2
Differences
.
| Characteristic | Prealbumin/Ceruloplasmin
Control Set | Predicate Device
Precinorm PUC (K040280). |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Human serum with material
of biological origin as
specified | Buffered aqueous solution |
| Format | Lyophilized | Liquid ready-for-use control
based on a buffered aqueous
solution. |
| Handling | Reconstitute with exactly 1.0
mL of distilled water and
allow to stand closed for 30
minutes to reconstitute, and
then mix gently. | Liquid ready-for-use control
based on a buffered aqueous
solution. Concentrations of
control components have been
adjusted to represent normal
ranges. |
| Evaluations summary | The Prealbumin/Ceruloplasmin Control Set was evaluated for value assignment and stability. A summary of the evaluation studies is provided in the Performance Characteristics Section of this submission. |
|---|---|
| Confidentiality | Roche Diagnostics Corporation requests that the FDA not disclose the nature or existence of the premarket notification until the substantial equivalence decision has been reached. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three curved lines that resemble a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the graphic. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corporation. c/o Ms. Corina Harper Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250
JAN 3 1 2007
Re: K062379
Trade/Device Name: Prealbumin/Ceruloplasmin Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: January 10, 2007 Received: January 11, 2007
Dear Ms. Harper:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
4
Page 2 --
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) 276-0450. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker J.
Robert L. Becker, Jr., M.D. Ph.D. Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KD62379
COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
Indications For Use:
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Prescription Use XXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Maria M Chan
Division Sign-Off
Page 1 of
Office of In Vitro D Device Evatuation a
Kob 2379