C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
Device Facts
| Record ID | K133330 |
|---|---|
| Device Name | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN |
| Applicant | Roche Diagnostics |
| Product Code | JIX · Clinical Chemistry |
| Decision Date | Nov 26, 2013 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Intended Use
C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin-ASLO-Ceruloplasmin) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. C.f.a.s. (Calibrator for automated systems) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. PreciControl ClinChem Multi 1 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. PreciControl ClinChem Multi 2 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. Precinorm Protein and Precipath Protein are for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Device Story
Device suite includes two calibrators (C.f.a.s. Proteins, C.f.a.s. PAC) and two control sets (PreciControl ClinChem Multi 1/2, Precinorm Protein/Precipath Protein). These are liquid or lyophilized serum-based products used on Roche/Hitachi and COBAS INTEGRA clinical chemistry analyzers. Primary modification involves replacing human-derived Antistreptolysin O source material with sheep-derived material to mitigate human-sourcing conflicts. Calibrators establish target values for quantitative assays; controls monitor accuracy and precision of these assays. Healthcare providers use analyzer-generated results to assess patient samples. Benefits include standardized calibration and reliable quality control for clinical chemistry testing, ensuring consistent diagnostic performance.
Clinical Evidence
Bench testing only. Submitter provided design control activities summary, risk analysis, and verification/validation data demonstrating that modified devices meet predetermined acceptance criteria.
Technological Characteristics
Serum-based calibrators and controls (liquid or lyophilized). Antistreptolysin O derived from sheep serum. Designed for use with Roche/Hitachi and COBAS INTEGRA clinical chemistry analyzers. Traceable to reference methods/materials via master lots. Stability maintained at 2-8°C.
Indications for Use
Indicated for use as calibrators (C.f.a.s. Proteins, C.f.a.s. PAC) or quality control materials (PreciControl ClinChem Multi 1/2, Precinorm Protein, Precipath Protein) for quantitative Roche clinical chemistry assays. Prescription use only.
Regulatory Classification
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.)
Special Controls
*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.
Predicate Devices
- C.f.a.s. Proteins (k080607)
- C.f.a.s. PAC (k040245)
- PreciControl ClinChem Multi 1 and 2 (k102016)
- Precinorm Protein and Precipath Protein (k981401)
Related Devices
- K993360 — PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA · Roche Diagnostics Corp. · Nov 24, 1999
Submission Summary (Full Text)
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| 510(k) # | k133330 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | The submission was prepared by Susan Hollandbeck from Roche Professional Diagnostics Regulatory Affairs and submitted on October 31, 2013. |
| | Roche Diagnostics Operations c/o Susan Hollandbeck 9115 South Hague Road; PO Box 50416; Indianapolis, IN 46250 Phone Number: 317-521-3380 Fax Number: 317-521-2324 e-mail: susan.hollandbeck@roche.com |
| Candidate device | There are four candidate devices: two calibrators and two control sets. Proprietary Names <ol><li>C.f.a.s. (Calibrator for automated systems) Proteins</li><li>C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin- Antistreptolysin-Ceruloplasmin)</li><li>PreciControl ClinChem Multi 1 and 2</li><li>Precinorm Protein and Precipath Protein</li></ol> |
| | Common Names <ol><li>C.f.a.s. Proteins</li><li>C.f.a.s. PAC</li><li>PCCC</li><li>PNP and PPP</li></ol> |
| Submission purpose | Roche Diagnostics submits this Bundled Special 510(k) as notification of device modifications. <ul><li>All four candidate devices bear the same modification; the Antistreptolysin O analyte source material, common to the two calibrators and two controls sets, has been changed from human serum to sheep serum to eliminate conflict associated with human sourcing.</li><li>C.f.a.s. PAC and PCCC have changed their biological additives.</li><li>C.f.a.s. PAC has two fewer because they are not needed and PCCC has one more because its levels were at risk of being too low.</li></ul> |
| Measurand | There are multiple constituents for each of the four devices. They are listed in the corresponding device labeling. |
NOV 2 6 2013
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The four candidate devices are modifications of the corresponding predicate Predicate device devices. The device names are unchanged. They and their most recent 510(k) submissions are summarized in the table below.
Table 1: Predicate Device Clearances
| Device | 510(k) Submission |
|-----------------------------------------|-------------------|
| C.f.a.s. Proteins | K080607 |
| C.f.a.s. PAC | K040245 |
| PreciControl ClinChem Multi 1 and 2 | K102016 |
| Precinorm Protein and Precipath Protein | K981401 |
Regulatory classification of device
| | | able 2: Regulatory Classification of Candidate Devices | |
|--|--|--------------------------------------------------------|--|
| | | | |
| Device | C.f.a.s. Proteins and C.f.a.s. PAC | PCCC and PNP/PPP |
|--------------|------------------------------------|--------------------------|
| Product Code | JIX | JJY |
| Device Class | II | I |
| Regulation | 862.1150 | 862.1660 |
| Description | Calibrator | Quality Control Material |
| Panel | Clinical Chemistry (75) | |
### Device description
C.f.a.s. Proteins is a liquid ready-to-use calibrator based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
C.f.a.s. PAC is a lyophilized calibrator based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
PreciControl ClinChem Multi 1 and 2 are lyophilized controls based on human serum. The adjusted concentrations and activities of the components of PCCC Multi 1 are usually in the normal range or at the normal/pathological threshold. The adjusted concentrations and activities of the components of PCCC Multi 2 are usually in the pathological range.
Precinorm Protein and Precipath Protein are liquid ready-for-use control sera based on human serum. The concentrations of the components of Precinorm Protein are usually in the normal range or at the normal/pathological threshold. The concentrations of the components of Precipath Protein are usually in the pathological range.
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| Intended use | The intended uses of the modified devices, as described in their labeling, have not changed as a result of the modifications. C.f.a.s. Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. C.f.a.s. PAC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. PreciControl ClinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. Precinorm Protein and Precipath Protein are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Special<br>conditions for<br>use | For prescription use only |
| Special<br>instruments<br>required | These calibrators and controls are designed for use with Roche clinical chemistry analyzers in the Roche/Hitachi and COBAS INTEGRA analyzer families. |
| | Continued on next page |
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Similarities -The following table compares the similar features of the candidate device, C.f.a.s. Proteins C.f.a.s. Proteins, to the predicate device that was cleared in 510(k) k080607.
the submit and the submit of the subject of the subject of
| Feature | Predicate Device | Candidate Device |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Intended use | C.f.a.s. Proteins is for use in the<br>calibration of quantitative Roche<br>methods on Roche clinical<br>chemistry analyzers as specified in<br>the value sheets. | Same |
| Levels | 1 | Same |
| Form | Liquid ready-to-use | Same |
| Matrix | Human serum with chemical and<br>biological additives | Same |
| Constituents | 16 constituents<br>(complete list is in Table 11) | Same |
| Traceability | Traceability of the target values is<br>given in the respective instructions<br>for use of the system reagents. | Same |
| Value assignment | Traceable through master lot to<br>reference methods or materials | Same |
| Unopened stability | 2 - 8 °C until expiration | Same |
| Opened stability | 4 weeks at 2 - 8 °C, provided that<br>dispensing of the calibrator occurs<br>without microbial contamination | Same |
Table 3: Similarities between Predicate and Candidate C.f.a.s. Proteins
Differences -The following table distinguishes the candidate device, C.f.a.s. Proteins, from C.f.a.s. Proteins the predicate device that was cleared in 510(k) k080607.
Table 4: Differences between Predicate and Candidate C.f.a.s. Proteins
| Feature | Predicate Device | Candidate Device |
|-----------------|--------------------------|--------------------------|
| Source material | Human Antistreptolysin O | Sheep Antistreptolysin O |
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#### The following table compares the similar features of the candidate device, Similarities -C.f.a.s. Proteins, to the predicate device that was cleared in 510(k) k080607. C.f.a.s PAC
| Feature | Predicate Device | Candidate Device |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Intended use | C.f.a.s. PAC is for use in the<br>calibration of quantitative Roche<br>methods on Roche clinical<br>chemistry analyzers as specified in<br>the value sheets. | Same |
| Levels | 1 | Same |
| Form | Lyophilized, requires reconstitution<br>with 1.0 mL water | Same |
| Matrix | Human serum with chemical and<br>biological additives | Same |
| Constituents | 3 constituents<br>(complete list is in Table 11) | Same |
| Traceability | Traceability of the target values is<br>given in the respective instructions<br>for use of the system reagents. | Same |
| Value assignment | Traceable through master lot to<br>reference methods or materials | Same |
| Unopened stability | 2-8 °C until expiration | Same |
| Reconstituted<br>stability | • 8 hours at 15 to 25 °C<br>• 2 days at 2 to 8 °C<br>• 2 weeks at -15 to -25 °C<br>(when frozen once) | Same |
Table 5: Similarities between Predicate and Candidate C fass PAC
### Differences -C.f.a.s. PAC
The following table distinguishes the candidate device, C.f.a.s. PAC, from the predicate device that was cleared in 510(k) k040245.
### Table 6: Differences between Predicate and Candidate C.f.a.s. PAC
| Feature | Predicate Device | Candidate Device |
|-------------------------|------------------------------------------|------------------------------------------|
| Source material | Human Antistreptolysin O | Sheep Antistreptolysin O |
| Biological<br>additives | Includes Ceruloplasmin and<br>Prealbumin | Excludes Ceruloplasmin<br>and Prealbumin |
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The following table compares the similar features of the candidate device, Similarities -PCCC PreciControl ClinChem Multi 1 and 2 (PCCC), to the predicate device that was cleared in 510(k) k102016.
| Feature | Predicate Device | Candidate Device |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Intended use | PreciControl ClinChem Multi 1 and<br>2 are for use in quality control by<br>monitoring accuracy and precision<br>for the quantitative methods as<br>specified in the value sheets. | Same |
| Levels | 2 | Same |
| Form | Lyophilized, requires reconstitution<br>with 5.0 mL water | Same |
| Matrix | Human serum with chemical and<br>biological additives | Same |
| Constituents | 49 constituents<br>(complete list is in Table 11) | Same |
| Traceability | Traceability of the target values is<br>given in the respective instructions<br>for use of the system reagents. | Same |
| Value assignment | Traceable through master lot to<br>reference methods or materials | Same |
| Unopened stability | 2-8 °C until expiration | Same |
| Reconstituted<br>stability | • 12 hours at 15 to 25 °C<br>• 5 days at 2 to 8 °C<br>• 4 weeks at -15 to -25 °C<br>(when frozen once) | Same |
Table 7: Similarities between Predicate and Candidate PCCC
#### The following table distinguishes the candidate device, PCCC, from the Differences -PCCCC predicate device that was cleared in 510(k) k102016.
### Table 8: Differences between Predicate and Candidate PCCC
| Predicate Device | Candidate Device |
|--------------------------|---------------------------|
| Human Antistreptolysin O | Sheep Antistreptolysin O |
| Excludes Ferritin | Includes Ferritin |
| | |
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#### The following table compares the similar features of the candidate devices, Similarities -PNP/PPPP Precinorm Protein (PNP) and Precipath Protein (PPP) to the predicate devices that were cleared in 510(k) k981401.
| Feature | Predicate Device | Candidate Device |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Precinorm Protein and<br>Precipath Protein Controls are<br>intended for use as controls in<br>the immunoturbidimetric<br>assay of serum proteins. | Precinorm Protein and<br>Precipath Protein are for use<br>in quality control by<br>monitoring accuracy and<br>precision for the quantitative<br>methods as specified in the<br>value sheets. |
| Levels | 2 | Same |
| Form | Liquid ready-to-use | Same |
| Matrix | Human serum with chemical<br>and biological additives | Same |
| Constituents | 18 constituents<br>(complete list is in Table 11) | Same |
| Traceability | Traceability of the target<br>values is given in the<br>respective instructions for<br>use of the system reagents. | Same |
| Value assignment | Traceable through master lot<br>to reference methods or<br>materials | Same |
| Unopened stability | 2 - 8 o C until expiration | Same |
| Opened stability | 1 month after first opening at<br>2 - 8 oC providing that<br>contamination by<br>microorganisms is avoided. | 4 weeks at 2 - 8 oC,<br>provided that dispensing of<br>the control occurs without<br>microbial contamination. |
Table 9: Similarities between Predicate and Candidate PNP/PPP
#### The following table distinguishes the candidate devices, PNP and PPP, from Differences -PNP/PPP the predicate devices that were cleared in 510(k) k981401.
| | Table 10: Differences between Predicate and Candidate PNP/PPP | | | | |
|--|---------------------------------------------------------------|--|--|--|--|
|--|---------------------------------------------------------------|--|--|--|--|
| Feature | Predicate Device | Candidate Device |
|-----------------|--------------------------|--------------------------|
| Source material | Human Antistreptolysin O | Sheep Antistreptolysin O |
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### Constituents
The four candidate devices include the listed constituent analytes. The list of constituents is unchanged between candidate and predicate devices. Table 11: Constituent Analytes of the Candidate Devices
| al-Acid glycoprotein<br>al-Antitrypsin<br>Antistreptolysin O1<br>C3c<br>C4<br>Ceruloplasmin<br>C-Reactive Protein<br>Ferritin<br>Haptoglobin<br>10. IgA<br>11. IgG | | ı. Prealbumin<br>2. Antistreptolysin O<br>3. Ceroluplasmin | 1.<br>2.<br>3.<br>4.<br>5.<br>6.<br>7. | C3c<br>C4 | al-Acid glycoprotein<br>al-Antitrypsin<br>Albumin<br>Antistreptolysin O |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------------------|---------------------------------------------------------------------|-----------------------|-------------------------------------------------------------------------|
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | Ceruloplasmin' |
| | | | 8. | | C-reactive protein |
| | | | | 9. Ferritin | |
| | | | | | 10. Haptoglobin |
| | | | | 11. IgA | |
| 12. IgM | | | | 12. IgG | |
| 13. Kappa | | | | 13. IgM | |
| | | | | | |
| 15. Prealbumin' | | | | | |
| 16. Transferrin | | | | | 16. Prealbumin' |
| | | | | | 17. Total Protein |
| | | | | | 18. Transferrin |
| | | | | | |
| PCCC | | | | | |
| Alanine aminotransferase | 18. | Ceruloplasmin | | ડર. | Lactate |
| Albumin | 19. | Chloride | | | dehydrogenase |
| Alkaline phosphatase | | Cholesterol | | 36. | LDL-Cholesterol |
| al-Acid glycoprotein | 21. | Cholinesterase | | 37. | Lipase |
| al-Antitrypsin | 22. | Creatine kinase | | 38. | Lithium |
| Amylase | 23. | Creatine kinase MB | | 39. | Magnesium |
| Amylase pancreatic | 24. | Creatinine | | 40. | Phosphate |
| Antisteptolysin O | 25. | Ferritin | | 41. | Potassium |
| Apolipoprotein A-1 | 26. | | | 42. | Prealbumin |
| Apolipoprotein B | 27. | Glucose | | 43. | Sodium |
| Aspartate aminotransferase | 28. | Haptoglobin | | 44. | Total protein |
| Bilirubin direct | 29. | HDL-Cholesterol | | 45. | Transferrin |
| Bilirubin total | 30. | IgA | | 46. | Triglycerides |
| C-Reactive protein | 31. | lgG | | 47. | Unsaturated |
| C3c | 32. | IgM | | | iron-binding |
| C4 | 33. | Iron | | | capacity |
| Calcium | 34. | Lactate | | 48. | Urea |
| | | | | 49. | Uric acid |
| | 14. Lambda | | The devices are not promoted in the U.S. for these analytes.<br>20. | y-GlutamyItransferase | 14. Kappa<br>15. Lambda |
Continued on next page
·
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| Performance<br>characteristics | These changes are supported by demonstrating no adverse impact to stability, method comparison, lower detection limit, control recovery, and precision. | | |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------|
| Stability | The shelf life stability claim and the open vial stability claims were re- evaluated with real time stability data. Results from all timepoints tested meet the acceptance criterion. The acceptance criterion for C.f.a.s. Proteins, C.f.a.s. PAC, PCCC, PNP, and PPP is that the averaged results must be 90% to 110% recovery of the reference value, except... The acceptance criterion for Antistreptolysin O in PNP/PPP is that the average results must be 85% to 115% recovery of the reference value. Results from all analytes from all four devices range from 91 to 108% recovery. The open vial stability claims appear in the device package inserts. They are supported with the new data. The unopened stability claim, or shelf life claim is seen by the user only as an expiration date on the device. | | |
| Method<br>comparison | Antistreptolysin O method comparison was conducted between the candidate and predicate C.f.a.s. PAC. The Hitachi and INTEGRA analyzer families use different Antistreptolysin O reagent formulations. The cobas c 501 analyzer tested the Hitachi reagent formulation and the INTEGRA 800 tested the INTEGRA reagent formulation. Passing-Bablok linear regression analysis was performed on the data set of human serum samples. The x-axis was set to C.f.a.s. PAC with the current calibrator formulation; the y-axis was set to the modified one. The table below summarizes results. | | |
| Table 12: Antistreptolysin O Method Comparison Results for C.f.a.s. PAC | | | |
| | Test System | Criteria | Results |
| | ASLOT c 501 | Slope = 1.00 ± 0.10<br>Intercept ≤ ± 20 IU/mL<br>R value ≥ 0.975 | Slope = 1.00<br>Intercept = -2 IU/mL<br>R value = 0.998 |
| | ASO 1800 | | Slope = 1.00<br>Intercept = 0 IU/mL<br>R value = 1.000 |
The candidate and predicate C.f.a.s. PAC compare well. Both test systems meet the criteria. There is no evidence of loss to patient sample accuracy as a result of the Antistreptolysin O source change.
Continued on next page
.
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| Lower<br>detection limit | Antistreptolysin O lower detection limit (LDL) was verified using the<br>candidate C.f.a.s. PAC to calibrate the ASLOT cobas c 501 test system. The<br>LDL represents the lowest measurable analyte concentration that can be<br>distinguished from zero. It is calculated as the value lying three standard<br>deviations above that of the lowest standard with n =21. The study showed<br>an LDL of 2 IU/mL which meets the criterion of ≤ 20 IU/mL, thus supported<br>the LDL claim of 20 IU/mL. |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control<br>recovery | Antistreptolysin O control recovery was tested with both candidate control<br>sets on both the cobas c 501 and the INTEGRA 800 analyzers. Results range<br>from 97 to 104% recovery of the target value. The acceptance criterion is 90<br>to 110%. All values meet the acceptance criterion. There is no evidence of<br>loss of accuracy due to the Antistreptolysin O source change. |
| Precision | The potential loss to reproducibility is evaluated by testing the precision of<br>Antistreptolysin O in both candidate control sets, PCCC and PNP/PPP, and of<br>Ferritin in PCCC. Antistreptolysin O precision data are collected using one<br>reagent batch on two analyzers, the cobas c 501 and the COBAS INTEGRA<br>800. Ferritin precision data are collected using one reagent batch on the<br>cobas c 501 analyzer because there is no Ferritin application on the COBAS<br>INTEGRA in the U.S. For each test system, 21 replicates were measured in a<br>single run in a single day. The coefficient of variation (%CV) was calculated. |
| | Antistreptolysin O and Ferritin precision results range from 0 to 2% CV. All Antistreptolysin O results must produce a CV ≤ 4%. All Ferritin results must produce a CV ≤ 5%. All results meet the criterion. Therefore, there is no evidence of loss to reproducibility as a result of the device modifications. |
| Conclusion | The submitted information in this premarket notification supports a substantial equivalence decision. The differences between predicate and candidate do not impact the indications for use or technological characteristics. |
. · ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
### ROCHE DIAGNOSTICS SUSAN HOLLANDBECK 9115 SOUTH HAGUE ROAD INDIANAPOLIS IN 46250
Re: K133330
Trade/Device Name: C.f.a.s. PAC; C.f.a.s. Proteins: Precicontrol ClinChem Multi 1 & 2; Precinorm Protein & Precipath Protein Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX, JJY Dated: October 31, 2013 Received: November 1, 2013
Dear Ms. Hollandbeck:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Hollandbeck
If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809). please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): k133330
C.f.a.s. PAC Device Name:
Indications for Use:
C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin-ASLO-Ceruloplasmin) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _______ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
k133330 510(k)
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510(k) Number (if known): k133330
Device Name: C.f.a.s. Proteins
Indications for Use:
C.f.a.s. (Calibrator for automated systems) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or .
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE UELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
k133330 510(k)
{14}------------------------------------------------
510(k) Number (if known): k133330
Device Name:
PreciControl ClinChem Multi 1 and 2
Indications for Use:
PreciControl ClinChem Multi I is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. PreciControl ClinChem Multi 2 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(Please do not write below this line; Continue on another Page if needed)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
k133330 510(k)
Page kxfxkx 3 of 4
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510(k) Number (if known): k133330
Precinorm Protein and Precipath Protein Device Name:
Indications for Use:
Precinorm Protein and Precipath Protein are for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
## Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
k133330 510(k)
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