(25 days)
C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers 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. Precipath ® and present 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.
C.f.a.s. PAC is a liquid, ready-for-use calibrator consisting of a buffered aqueous solution with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in the product labeling.
Precinorm ® PUC/ Precipath ® PUC is a liquid ready-for-use control based on a buffered aqueous solution. Concentrations of control components have been adjusted to represent normal and pathological ranges. Values for constituent analytes are provided in the product labeling.
This looks like a 510(k) Pre-market Notification for a medical device. The provided text is a summary of the similarities between a new device and an existing "predicate" device, which is the basis for claiming "substantial equivalence" to qualify for FDA approval.
However, the provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria. Instead, it focuses on demonstrating that the new devices (C.f.a.s. PUC, Precinorm® PUC, and Precipath® PUC) are substantially equivalent to their previously cleared predicate devices by highlighting their shared intended use, format, stability, and the analytes they measure.
The key information is that the new devices have added Immunoglobulin G to the list of constituent analytes compared to their predicates. The company is asserting that despite this addition, the new devices are still substantially equivalent.
Therefore, many of the questions you've asked cannot be answered directly from the provided text, as it's not a study report detailing performance against specific criteria, but rather a regulatory submission for substantial equivalence.
Here's an attempt to answer based on the information provided and what can be inferred:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance in the way a clinical study report would. The "performance" being demonstrated here is the substantial equivalence to predicate devices. The implicit acceptance criterion for this submission is that the modifications (addition of Immunoglobulin G as an analyte) do not raise new questions of safety and effectiveness, and the device performs as expected for a calibrator/quality control.
| Acceptance Criteria (Implied for Substantial Equivalence Claim) | Reported Device Performance (Summary of Similarities) |
|---|---|
| C.f.a.s. PUC: | |
| - Intended Use is the same as predicate. | - Same: Calibration of quantitative Roche methods on Roche clinical chemistry analyzers. |
| - Format is the same as predicate. | - Same: Liquid, ready-for-use calibrator, buffered aqueous solution, biological materials. |
| - Stability is the same as predicate. | - Same: Unopened stable at 2-8°C until expiration; Opened stable at 2-8°C for 4 weeks. |
| - Level is the same as predicate. | - Same: Single level. |
| - Constituent Analytes are similar or safely expanded. | - Added Immunoglobulin G (IgG) to Albumin and Total protein. The submission implies this addition does not change substantial equivalence from the predicate which had only Albumin and Total protein. Although not explicitly stated as performance, the implication is that the device accurately calibrates for IgG. |
| Precinorm® PUC / Precipath® PUC: | |
| - Intended Use is the same as predicate. | - Same: Quality control by monitoring accuracy and precision for quantitative methods. |
| - Format is the same as predicate. | - Same: Liquid, ready-for-use control, buffered aqueous solution, concentrations adjusted for normal and pathological ranges. |
| - Stability is the same as predicate. | - Same: Unopened stable at 2-8°C until expiration; Opened stable at 2-8°C for 4 weeks. |
| - Constituent Analytes are similar or safely expanded. | - Precinorm®: Added Immunoglobulin G (IgG) to Albumin, Creatinine, Total Protein. - Precipath®: Added Immunoglobulin G (IgG) to Albumin, Creatinine, Total Protein, Immunoglobulin A, Immunoglobulin M. The submission implies this addition does not change substantial equivalence from the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. This document isn't a study report with test set details. For a calibrator/control device, testing typically involves assessing accuracy, precision, linearity, and stability, but the details of such assessments are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. This device is a calibrator and control, not an interpretative diagnostic device that would require expert "ground truth" establishment in the context of clinical images or patient data. The "ground truth" for calibrators and controls is established through rigorous analytical methods to assign target values to the analytes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As above, this type of adjudication is relevant for diagnostic devices that interpret patient data, not for calibrators/controls that undergo analytical validation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. MRMC studies are used for diagnostic devices, particularly imaging AI, not for calibrators/controls. This device does not involve human readers' interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. There is no "algorithm" in the sense of AI performance for this type of device. The device's performance relates to its chemical and physical properties as a calibrator/control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for calibrators and controls is established through assigned values derived from highly accurate and precise analytical reference methods, often traceable to international reference materials. While the specific methods used to assign values for C.f.a.s. PUC, Precinorm® PUC, and Precipath® PUC are not detailed in this summary, it would typically involve:
- Reference materials: Using certified reference materials or reference measurement procedures to ensure accuracy.
- Method validation: Thorough validation of the methods used for value assignment.
- Traceability: Ensuring traceability of assigned values to higher-order reference measurement systems.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set, this question is not relevant.
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JAN 3 1 2005
510(k) Summary – C.f.a.s. (Calibrator for Automated Systems) PUC (Proteins in Urine/CSF); Precinorm ® PUC and Precipath ® PUC
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence |
|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RdIndianapolis IN 46250(317) 521-3723 |
| Contact person: Theresa M. Ambrose | |
| Date prepared: January 5, 2005 | |
| Device 1 Name | Proprietary name: Roche Diagnostics C.f.a.s. (Calibrator for automatedsystems) PUC (Proteins in Urine/CSF) |
| Common name: C.f.a.s. PUC | |
| Classification name: Calibrator, multi-analyte mixture | |
| Device 2 Name | Proprietary name: Roche Diagnostics Precinorm® PUC (Proteins inUrine/CSF) and Precipath® PUC (Proteins in Urine/CSF |
| Common name: Precinorm® PUC / Precipath® PUC | |
| Classification name: Multi-analyte controls, all kinds (assayed andunassayed) | |
Continued on next page
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:
| Device 1description | C.f.a.s. PAC is a liquid, ready-for-use calibrator consisting of a bufferedaqueous solution with biological materials added as required to obtain desiredcomponent levels. Values for constituent analytes are provided in the productlabeling. |
|---|---|
| Device 2description | Precinorm ® PUC/ Precipath ® PUC is a liquid ready-for-use control basedon a buffered aqueous solution. Concentrations of control components havebeen adjusted to represent normal and pathological ranges. Values forconstituent analytes are provided in the product labeling. |
| Device 1Intended use | C.f.a.s. PUC is for use in the calibration of quantitative Roche methods onRoche clinical chemistry analyzers as specified in the enclosed value sheet. |
| Device 2Intended use | Precinorm ® PUC/ Precipath ® PUC is for use in quality control bymonitoring accuracy and precision for the quantitative methods as specified inthe enclosed value sheet |
| Device 1SubstantialEquivalence | For C.f.a.s. PUC, Roche claims substantial equivalence to the currentlymarketed currently marketed C.f.a.s. PUC, K040264. |
| Substantialequivalencecomparison -Device 1 | The table below compares C.f.a.s. PUC with its predicate device (currentlymarketed C.f.a.s. PUC, K040264). |
| Continued on next page |
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| Characteristic | C.f.a.s. PUC (Predicate device, K040264) | C.f.a.s. PUC (Modified Device) |
|---|---|---|
| Intended Use | C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. | Same |
| Format | Liquid ready-for-use calibrator based on a buffered aqueous solution. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. | Same |
| Stability | UnopenedStable at 2-8°C until expiration dateOpened:Stable at 2 to 8°C for 4 weeks | Same |
| Level | Single level | Same |
| ConstituentAnalytes withAssignedValues | • Albumin• Total protein | • Albumin• Total protein• Immunoglobulin G |
| Device 2 For Precinorm ® PUC and Precipath ® PUC, Roche claims substantial |
| SubstantialEquivalence | For Precinorm ® PUC and Precipath ® PUC, Roche claims substantialequivalence to the currently marketed Roche Diagnostics Precinorm ® PUCand Precipath ® PUC (K041812). |
|---|---|
| SubstantialEquivalence -Devicecomparison | The table below compares Precinorm ® PUC / Precipath® PUC with thepredicate device (currently marketed Precinorm ® PUC / Precipath® PUC). |
Continued on next page
,
: 上一篇:
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| Characteristic | Precinorm ® PUC / Precipath®PUC (Predicate device, K040264) | Precinorm ® PUC /Precipath® PUC (ModifiedDevice) |
|---|---|---|
| Intended Use | For use in quality control bymonitoring accuracy and precisionfor the quantitative methods asspecified in the enclosed value sheet | Same |
| Format | Liquid ready-for-use control basedon a buffered aqueous solution.Concentrations of controlcomponents have been adjusted torepresent normal and pathologicalranges. | Same |
| Stability | UnopenedStable at 2-8°C until expiration dateOpened:Stable at 2 to 8°C for 4 weeks | Same |
| Constituent Analyteswith Assigned Values | Precinorm | Precinorm |
| • Albumin• Creatinine• Total Protein | • Albumin• Creatinine• Total Protein• Immunoglobulin G | |
| Precipath | Precipath | |
| • Albumin• Creatinine• Total Protein• Immunoglobulin A• Immunoglobulin M | • Albumin• Creatinine• Total Protein• Immunoglobulin A• Immunoglobulin M• Immunoglobulin G |
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| Characteristic | Precinorm ® PUC / Precipath®PUC (Predicate device, K040264) | Precinorm ® PUC /Precipath® PUC (ModifiedDevice) |
|---|---|---|
| Intended Use | For use in quality control bymonitoring accuracy and precisionfor the quantitative methods asspecified in the enclosed value sheet | Same |
| Format | Liquid ready-for-use control basedon a buffered aqueous solution.Concentrations of controlcomponents have been adjusted torepresent normal and pathologicalranges. | Same |
| Stability | UnopenedStable at 2-8°C until expiration dateOpened:Stable at 2 to 8°C for 4 weeks | Same |
| Constituent Analyteswith Assigned Values | Precinorm• Albumin• Creatinine• Total ProteinPrecipath• Albumin• Creatinine• Total Protein• Immunoglobulin A• Immunoglobulin M | Precinorm• Albumin• Creatinine• Total Protein• Immunoglobulin GPrecipath• Albumin• Creatinine• Total Protein• Immunoglobulin A• Immunoglobulin M• Immunoglobulin G |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, PhD, RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250
K050026 Re:
K050020
Trade/Device Name: C.f.a.s (Calibrator for Automated Systems) Proteins in Urine/CSF (PUC) Precinorm® Proteins in Urine/CSF (PUC) and Precipath ® PUC
JAN 3 1 2005
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: January 5, 2005 Received: January 6, 2005
Dear Dr. Ambrose:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Soctor 9 rotty premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobars) to 16garry the enactment date of the Medical Device Amendments, or to conninered price to May 20, 1970, the ecordance with the provisions of the Federal Food, DINA de vices that have occh roomsonied in assee approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The I ou may, arere, mains 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 n may or bable of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of acress 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 or any 1 vith 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) i his letter will anow you to obgin manically your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarked notification: "The PDA Intentig of casification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements o your device, of fu If you desire specific information acour are app a martice, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the Ville Dagliostic Device Device and reason to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the 1 ou may ovant other general meritational 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,
Sean M. Cooper MS, DVM
Jean 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
{7}------------------------------------------------
Indications for Use
K050026 510(k) Number (if known): -
Device Name: Precinorm ® Proteins in Urine/CSF (PUC) and Precipath ® PUC
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 ® and present 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.
Prescription Use X (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
Office of In Vitro Diagnosiic Device Evaluation and St
510(k) K07026
Page 1 of
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Indications for Use
510(k) Number (if known):
Device Name:_C.f.a.s. (Calibrator for Automated Systems) Proteins in Urine/CSF (PUC)
Indications For Use:
C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
cting
Division Sign-Off
e of In Vitro Diagnostic vice Evaluation and Safety Page 1 of ____________________________________________________________________________________________________________________________________________________________________
24
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.