(34 days)
Not Found
No
The summary describes quality control materials for laboratory tests, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is described as a quality control material for monitoring the accuracy and precision of quantitative methods, not for treating or diagnosing any medical condition.
No
The device is a quality control material used for monitoring the accuracy and precision of quantitative methods, not for diagnosing diseases or conditions in patients.
No
The device description explicitly states it consists of a buffered aqueous solution with biological materials, indicating it is a physical control material, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the product is "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet." This indicates that the device is used to evaluate the performance of other diagnostic tests performed in vitro (outside the body).
- Device Description: The description mentions a "buffered aqueous solution with biological materials added" and that "Values for constituent analytes are provided in product labeling." This aligns with the typical composition and labeling of IVD control materials.
- Predicate Device: The mention of a predicate device (K981401; Roche Diagnostic Precinorm Protein Precipath Protein Controls) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for new IVDs.
The purpose of these controls is to ensure the reliability and accuracy of laboratory tests that measure proteins in urine and CSF, which are common diagnostic procedures performed in vitro.
N/A
Intended Use / Indications for Use
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. Precipath 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.
Product codes
JJY
Device Description
The Precinorm PUC and Precipath PUC Controls consist of a buffered aqueous solution with biological materials added as required to obtain desired component levels in either the normal or pathological range. Values for constituent analytes are provided in product labeling.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
| MAR 1 1 2004 | |
|---|---|
| 510(k) Summary | |
| 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 |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 521 - 3831 |
Contact Person: Sherri L Coenen
Date Prepared: February 6, 2004 |
| Device Name | Proprietary name: Precinorm Proteins in Urine/CSF and Precipath Proteins in Urine/CSF Controls
Common name: Precinorm PUC Precipath PUC
Classification name: Multi-analyte Controls, All Kinds (assayed and unassayed) |
| Device
Description | The Precinorm PUC and Precipath PUC Controls consist of a buffered aqueous solution with biological materials added as required to obtain desired component levels in either the normal or pathological range. Values for constituent analytes are provided in product labeling. |
| Intended use | 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.
Precipath 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. |
:
1
510(k) Summary, Continued
Substantial Equivalence
The Precinorm PUC and Precipath PUC Controls are substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostic Precinorm Protein Precipath Protein Controls. (K981401). The intended use of both devices is quality control of their respective test systems.
Substantial equivalence similarities
The following table compares the Precinorm PUC and Precipath PUC Controls with the predicate device.
and the same of the same of the same of the same of the same of the same of
| Feature | Precinorm PUC
Precipath PUC | Precinorm Protein
Precipath Protein
(Predicate Device) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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.
Precipath 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. | Precinorm Protein and
Precipath Protein are used for
quality control of the
quantitative determination of
serum proteins. The controls
are used for monitoring
accuracy and precision both
for manual techniques and for
assays on automated clinical
chemistry analyzers. |
| Format | Liquid ready-for-use control
based on a buffered aqueous
solution. Concentrations of
control components have been
adjusted to represent normal
and pathological ranges. | Liquid ready-for-use control
based on human serum.
Concentrations of control
components have been
adjusted to represent normal
and pathological ranges. |
| Stability | Same | • Unopened: Stable at 2-8°C
until expiration date.
• Opened: Stable for 4 weeks
at 2-8°C. |
ﻳﺎ
2
510(k) Summary, Continued
Substantial equivalence differences
Comparison of proposed Precinorm PUC and Precipath PUC Controls and predicate device.
| Feature | Precinorm PUC
Precipath PUC | Precinorm Protein
Precipath Protein
(Predicate Device) |
|---------|--------------------------------|--------------------------------------------------------------|
| Matrix | Buffered aqueous solution | Stabilized human serum |
| Constituent Analytes | |
|---|---|
| Precinorm PUC | |
| Precipath PUC | Precinorm Proteins |
| Precipath Proteins | |
| (Predicate Device) | |
| Albumin | α1-acid glycoprotein |
| Creatinine | Albumin |
| Total Protein | α1-antitrypsin |
| Urine/CSF Protein | Antistreptolysin O |
| C3c | |
| C4 | |
| Ceruloplasmin | |
| C-Reactive Protein | |
| Ferritin | |
| Haptoglobin | |
| IgA | |
| IgG | |
| IgM | |
| Prealbumin | |
| Total Protein | |
| Transferrin |
Constituent Analytes
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three wavy lines representing the staff and a stylized head representing the snake.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
mar 1 1 2004
Ms Sherri L. Coenen Regulatory Affairs Associate Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K040280
Trade/Device Name: Precinorm PUC and Precipath PUC Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 6, 2004 Received: February 6, 2004
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,
Jean M. Cooper, MS, DVM.
Yean 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
5
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Precinorm PUC and Precipath PUC Controls
Indications For Use:
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.
Precipath PUC (Proteins ir: Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Carol C Benson
Division Sign Off
Division Sign-Of
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K040280