(34 days)
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.
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.
The provided text describes a 510(k) submission for the "Precinorm PUC and Precipath PUC Controls" and focuses on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.
The 510(k) summary primarily compares the new device to a predicate device (Roche Diagnostic Precinorm Protein Precipath Protein Controls, K981401) in terms of:
- Intended Use: Both are for quality control by monitoring accuracy and precision for quantitative methods. The key difference is that the new device specifies "Proteins in Urine/CSF," while the predicate specifies "serum proteins."
- Format: Both are liquid, ready-for-use controls with concentrations adjusted to represent normal and pathological ranges. The new device is a buffered aqueous solution, while the predicate is based on human serum.
- Stability: Stated as "Same" for the new device, with the predicate's stability detailed (unopened: stable at 2-8°C until expiration; opened: stable for 4 weeks at 2-8°C).
- Matrix: The new device uses a buffered aqueous solution, while the predicate uses stabilized human serum.
- Constituent Analytes: There are significant differences in the specific analytes listed for each device. The new device lists Albumin, Creatinine, Total Protein, and Urine/CSF Protein. The predicate device lists a much broader range of serum proteins.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such details are not present in the provided text.
The document is a regulatory submission for substantial equivalence, which primarily involves comparing a new device to an already legally marketed predicate device to demonstrate that it is as safe and effective. It does not detail specific performance studies with acceptance criteria in the manner one might find for a novel diagnostic algorithm or drug.
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| 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. |
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250(317) 521 - 3831Contact Person: Sherri L CoenenDate Prepared: February 6, 2004 |
| Device Name | Proprietary name: Precinorm Proteins in Urine/CSF and Precipath Proteins in Urine/CSF ControlsCommon name: Precinorm PUC Precipath PUCClassification name: Multi-analyte Controls, All Kinds (assayed and unassayed) |
| DeviceDescription | 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. |
:
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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 PUCPrecipath PUC | Precinorm ProteinPrecipath Protein(Predicate Device) |
|---|---|---|
| Intended Use | Precinorm PUC (Proteins inUrine/CSF) is for use inquality control by monitoringaccuracy and precision for thequantitative methods asspecified in the enclosed valuesheet.Precipath PUC (Proteins inUrine/CSF) is for use inquality control by monitoringaccuracy and precision for thequantitative methods asspecified in the enclosed valuesheet. | Precinorm Protein andPrecipath Protein are used forquality control of thequantitative determination ofserum proteins. The controlsare used for monitoringaccuracy and precision bothfor manual techniques and forassays on automated clinicalchemistry analyzers. |
| Format | Liquid ready-for-use controlbased on a buffered aqueoussolution. Concentrations ofcontrol components have beenadjusted to represent normaland pathological ranges. | Liquid ready-for-use controlbased on human serum.Concentrations of controlcomponents have beenadjusted to represent normaland pathological ranges. |
| Stability | Same | • Unopened: Stable at 2-8°Cuntil expiration date.• Opened: Stable for 4 weeksat 2-8°C. |
ﻳﺎ
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510(k) Summary, Continued
Substantial equivalence differences
Comparison of proposed Precinorm PUC and Precipath PUC Controls and predicate device.
| Feature | Precinorm PUCPrecipath PUC | Precinorm ProteinPrecipath Protein(Predicate Device) |
|---|---|---|
| Matrix | Buffered aqueous solution | Stabilized human serum |
| Constituent Analytes | |
|---|---|
| Precinorm PUCPrecipath PUC | Precinorm ProteinsPrecipath 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
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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 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
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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
§ 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.