(32 days)
The ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur VB12 assay.
The ADVIA Centaur® Total hCG (ThCG) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay.
The ADVIA Centaur® Testosterone (TSTO) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur Testosterone assay.
ADVIA Centaur® Vitamin B12 Master Curve Material is an in vitro diagnostic product containing various levels of vitamin B12 in buffered human serum albumin with sodium azide (0.2%) and preservatives. Each set contains six levels (MCM1-6); with a fill volume of 1.0 mL per level. VB12 MCMs are ready-to-use liquid products. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 100, 250, 500, 1000, and 2200 pg/mL.
ADVIA Centaur® ThCG Master Curve Materials is an in vitro diagnostic product containing various levels of ThCG in lyophilized equine serum with preservatives including amphotericin B. Each set contains ten lyophilized levels (MCM1-10); with a reconstituted volume of 1.0 mL each. MCM1 contains no analyte. The ThCG MCMs assigned values are lot specific of target values: 0.0, 5.00, 10.0, 25.0, 50.0, 100, 250, 500, 750, and 1400 mIU/mL.
ADVIA Centaur® TSTO Master Curve Materials is an in vitro diagnostic product containing various levels of testosterone spiked in lyophilized human plasma with sodium azide and preservatives. Each set contains seven lyophilized levels (MCM1-7); with a reconstituted volume of 1.0 mL each. MCMI contains no analyte. The TSTO MCMs assigned values are lot specific of target values 0.00, 50.0, 100, 500, 750, 1000, and 1600 ng/dL.
Acceptance Criteria and Study for ADVIA Centaur® VB12 Master Curve Material
The document describes three separate Master Curve Materials (MCMs): VB12, ThCG, and TSTO. This analysis focuses specifically on the ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ADVIA Centaur® VB12 MCMs primarily relate to their stability. The study demonstrated that the device met these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Real Time/Shelf Life (Unopened) | - MCM1: Dose recovery ≤ 45 pg/mL - MCM2: % dose recovery within 75% to 125% - MCM3-6: % dose recovery within 85% to 115% (All calculated back to Day 0 and/or no adverse trends) | Met acceptance criteria up to the 15 months' time point, supporting a shelf-life claim of 14 months. Unopened storage shelf-life is indicated by the expiration date on the vial label. |
| On-Board Stability | - MCM1: Dose recovery ≤ 45 pg/mL - MCM2: % dose recovery within 75% to 125% - MCM3-6: % dose recovery within 85% to 115% (All calculated to T=0) | Met acceptance criteria up to 5 hours, supporting an on-board stability claim of 4 hours. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The test set for stability studies consisted of "Test VB12 MCMs" which were individual levels of the Master Curve Material (MCM1-6).
- Sample Size:
- Real Time/Shelf Life: Not explicitly stated as a number of individual samples, but likely involved multiple aliquots of each MCM level (MCM1-6) stored and tested at T=0, 6 months, 12 months, and 15 months. The exact number of replicates per time point is not specified but implied to be sufficient for a robust assessment.
- On-Board Stability: Not explicitly stated as a number of individual samples, but "Pooled aliquots of test VB12 MCMs in sample cups" were used and measured at T=0, 2, 4, and 5 hours. The exact number of replicates per time point is not specified.
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin). The studies appear to be prospective as they involved controlled storage and testing over defined time intervals to assess stability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device is a Quality Control (QC) material, not a diagnostic device requiring human interpretation of clinical images or data. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists) does not apply. The "ground truth" for the performance of this QC material is established by analytical testing against defined reference materials and specifications.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1, 3+1) is not applicable here. The performance is assessed by comparing dose recovery results to pre-defined numerical acceptance criteria for stability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret clinical cases, often with and without AI assistance. This device is a quality control material for an in-vitro diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance study (stability) is inherently "standalone" in the sense that it evaluates the material's integrity over time without human-in-the-loop performance, as it's a quality control product. The assay itself for which this MCM is used is automated.
7. The Type of Ground Truth Used
The ground truth for the VB12 MCM is established through:
- Traceability to a recognized standard: The assigned reference calibrators are prepared using USP (United States Pharmacopeia) VB12 stock and are traceable to USP internal material.
- Defined analytical specifications: The dose recovery acceptance criteria (e.g., ≤ 45 pg/mL, % recovery ranges) serve as the "ground truth" for determining if the material remains stable and performs as expected.
- Manufacturing procedures: MCMs are manufactured using "qualified materials and measurement procedures."
8. The Sample Size for the Training Set
This device is a physical Master Curve Material (MCM), not a machine learning model that requires a "training set" in the conventional sense. The "value assignment" process could be considered analogous to establishing its baseline characteristics.
For value assignment of a new VB12 MCM lot:
- MCM1: Run in 5 replicates on two separate runs using one reagent kit lot.
- MCM2-MCM6: Tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot.
9. How the Ground Truth for the Training Set Was Established
As noted above, there isn't a "training set" in the machine learning context. However, the process by which the "ground truth" or assigned values for the MCMs are established is described as follows:
- Reference Calibrators: The ADVIA Centaur VB12 MCMs are value assigned using assigned reference calibrators. These calibrators are prepared using USP (United States Pharmacopeia) VB12 stock and are traceable to USP internal material.
- Value Assignment Process:
- MCM1's target is 0.0 dose, and its quality control specifications ensure it measures at or below the assay sensitivity limit.
- A nested testing run protocol is used for MCM2-MCM6, involving running alternating samples of the reference and new MCM level in the same run to remove system and run variation.
- Resulting MCM dose values are generated using a two-point calibration.
- The new MCM dose is calculated based on the relationship between the observed reference MCM dose and its assigned value.
- Performance Verification: A performance verification run with 6 replicates of each MCM level (using one instrument, one reagent kit lot, and Bio-Rad controls) is conducted. The mean MCM doses of the new lot must fall within customer range specifications.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
Section 006: 510(k) Summary
510(k) Summary - ADVIA Centaur VB12 Master Curve Material
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K140505
| 1. Applicant InformationMailing Address: | Siemens Healthcare Diagnostics Inc.511 Benedict AvenueTarrytown, NY 10591 USA |
|---|---|
| Contact Person: | Fatima PachecoRegulatory Clinical Affairs Specialist |
| Phone Number: | (914) 524-2450 |
| Fax Number: | (914) 524-3579 |
| E-mail Address: | fatima.pacheco@siemens.com |
| Date Prepared: | February 24, 2014 |
| 2. Device NameProprietary Name:Measurand:Type of Test: | ADVIA Centaur® Vitamin B12 (VB12) Master Curve MaterialQuality Control materials for ADVIA Centaur VB12 assayMaster Curve Material (MCM) for ADVIA Centaur VB12 assay21 CFR 862.1660, Quality Control Material |
| Regulation Section: | Class I Reserved |
| Classification: | JJX - Single (Specified) Analyte Controls (Assayed and |
| Products Code: | Unassayed) |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device NamePredicate 510(k) No: | Elecsys Vitamin B12 CalCheckK060755 |
| 4. Device Description: | ADVIA Centaur® Vitamin B12 Master Curve Material is anin vitro diagnostic product containing various levels of vitaminB12 in buffered human serum albumin with sodium azide (0.2%)and preservatives. Each set contains six levels (MCM1-6); witha fill volume of 1.0 mL per level. VB12 MCMs are ready-to-use |
500, 1000, and 2200 pg/mL.
liquid products. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 100,250,
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ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| ADVIA Centaur® VB12, tHCG, and ISTO Master Curve Material (MCM) | |
|---|---|
| CAUTION! POTENTIAL BIOHAZARD: Contains humansource material. While each human serum or plasma donor unitused in the manufacture of this product was tested by FDA-approved methods and found nonreactive for hepatitis B surfaceantigen (HBsAg), antibody to hepatitis C (HCV), and antibodyto HIV-1/2, all products manufactured using human sourcematerial should be handled as potentially infectious. Because notest method can offer complete assurance that hepatitis B or Cviruses, HIV, or other infectious agents are absent, theseproducts should be handled according to established goodlaboratory practices. | |
| 5. Intended Use:Indication for Use: | See Indications for Use Statement below:The ADVIA Centaur® Vitamin B12 (VB12) Master CurveMaterial is for in vitro diagnostic use in the verification ofcalibration and reportable range of the ADVIA Centaur VB12assay. |
| Special Conditions forUse Statement(s): | For prescription use only |
| Special InstrumentRequirements: | ADVIA Centaur® SystemsA description of the ADVIA Centaur system is documentedin K971418. Subsequent modifications to the instrument havebeen reviewed and cleared in K032525 and K041133. |
| 6. Technological Characteristicsand Substantial EquivalenceComparison with Predicate: | A comparison of the device features, intended use, and otherinformation demonstrates that the ADVIA Centaur VB12 MCMis substantially equivalent to the predicate device assummarized in Table 1 |
{2}------------------------------------------------
(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur VB12 MCM | Elecsys Vitamin B12 CalCheck |
| IntendedUse | The ADVIA Centaur Vitamin B12(VB12) Master Curve Material is for invitro diagnostic use in the verificationof calibration and reportable range ofthe ADVIA Centaur VB12 assay. | For use in the verification of thecalibration established by the ElescysVitamin B12 reagent on the indicatedElecsys and cobas e immunoassayanalyzers. |
| Analyte | Vitamin B12 | Same |
| Use | Multiple Use | Same |
| Storage | 2–8°C | Same |
| DIFFERENCES | ||
| Form | Liquid | Lyophilized |
| Matrix | Human Serum Albumin | Human Serum |
| Levels | 6 | 3 |
| Stability | Unopened - Stable when storedunopened at 2-8°C until the expirationdate on the vial label.Opened - Stable on-board for 4 hours. | Unopened - Stable at 2-8°C up tothe expiration date printed on thebottle labels.Reconstituted - Stable for 4 hours at20-25°C. |
| Table 1: Substantial Equivalence Comparison | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------------------- |
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- CEN 13640 Stability Testing of In Vitro Diagnostic Reagents .
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic . Calibrators
- Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control . Material
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration checks of the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
9. Performance Characteristics
9.1 Analytical performance:
The following studies are not applicable for the purpose of this submission:
- Precision/Reproducibility . .
- Linearity/Assay Reportable Range
- Detection limit .
- . Analytical Specificity
- Assay cut-off ●
- Method Comparison Studies .
- Clinical Studies (Sensitivity, Specificity, and cut-off) .
9.2 Non-Clinical Performance Testing
9.2.1 Stability Studies
Stability studies were conducted to support the shelf life (unopened) and on-board (opened) material for the ADVIA Centaur VB12 MCMs to ensure that it maintains optimal product performance throughout the established shelf-life. The data supports the stability claims detailed in the ADVIA Centaur VB12 MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur VB12 MCM:
- Real Time/Shelf Life (unopened) .
- . On-Board
Real time shelf-life studies (unopened): Test VB12 MCMs were stored unopened at 2-8℃ and tested at T=0 and at the following time points: 6 months, 12 months, and 15 months. Shelf life claims are based upon real time stability carried out one month after the duration claimed. Real time shelf-life stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the real-time stability study were met up to the 15 months' time point, which supports a shelf-life claim of 14 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
On-board Stability: Pooled aliquots of test VB12 MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. On-board stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the onboard stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur VB12 MCM are as follows:
- . Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ≤ 45 pg/mL dose; MCM2, the % dose recovery must be within 75 to 125%; MCM3-6, the % dose recovery must be within 85 to 115% calculated back to Day 0 and/or no adverse trends.
- . On-Board: The dose recovery for MCM1 must be ≤ 45 pg/mL dose: MCM2. the % dose recovery must be within 75 to 125%; MCM3-6, the % dose recovery must be within 85 to 115% calculated to T=0.
9.2.2 Value Assignment
The ADVIA Centaur VB12 MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) VB12 stock and are traceable to USP internal material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new VB12 MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing run protocol is used for MCM2-MCM6 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-MCM6 were tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot. This protocol is designed to remove system and run variation. The new MCM doses must fall within the final value assignment specification for VB12 MCMs. The MCMs dose values are generated using the two-point calibration. The new MCM dose is calculated based on the relationship between the observed reference MCM dose and its assigned value. A performance verification run consisting of 6 replicates of each MCM level is run using one instrument, one reagent kit lot and Bio-Rad controls. The mean MCM doses of the new MCM lot manufactured must fall within the customer range specifications.
The target for MCM1 is assigned a 0.0 dose. The quality control specifications and final value assignment limits for VB12 MCM ensure that MCM1 measures at or below the VB12 assay sensitivity limit. MCM6 targeted greater than the assay range is diluted with the MCM1 to meet the reportable range of the assay.
9.2.3 Expected Values
The expected values are the lot-specific assigned values obtained at value assignment and the lot-specific assigned ranges are the lot-specific customer ranges are determined per % interval on page 6.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 50% |
| MCM3 | 25% |
| MCM4 | 25% |
| MCM5 | 25% |
| MCM6 | 20% |
Lot-specific assigned values and ranges are provided in the ADVIA Centaur VB12 MCM lot-specific value sheet in the example provided in Table 2.
| MCM Level | Target Values(pg/mL) | Assigned Values(pg/mL) |
|---|---|---|
| MCM1 | 0 | 0.00 |
| MCM2 | 100 | 99.7 |
| MCM3 | 250 | 218 |
| MCM4 | 500 | 469 |
| MCM5 | 1000 | 1099 |
| MCM6 | 2200 | 2309 |
| Assay Range | 45-2000 pg/mL (33-1476 pmol/L) |
Table 2: Example Lot-specific VB12 MCM Target and Assigned Values
9.2.4 Traceability
The ADVIA Centaur VB12 assay is traceable to an internal standard manufactured using U.S.P. (United States Pharmacopeia) material. Assigned values for calibrators and MCMs are traceable to this standardization. The VB12 MCMs are manufactured using qualified materials and measurement procedures.
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur VB12 Master Curve Material (MCM) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys Vitamin B12 CalCheck. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur VB12 Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
510(k) Summary - ADVIA Centaur ThCG Master Curve Material
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K140505
| 1. Applicant InformationMailing Address: | Siemens Healthcare Diagnostics Inc.511 Benedict AvenueTarrytown, NY 10591 USA |
|---|---|
| Contact Person: | Fatima PachecoRegulatory Clinical Affairs Specialist |
| Phone Number: | (914) 524-2450 |
| Fax Number: | (914) 524-3579 |
| E-mail Address: | fatima.pacheco@siemens.com |
| Date Prepared: | February 24, 2014 |
| 2. Device NameProprietary Name: | ADVIA Centaur® Total hCG Master Curve MaterialQuality Control materials for ADVIA Centaur Total hCG assay |
| Measurand:Type of Test: | Master Curve Material (MCM) for ADVIA Centaur Total hCGassay |
| Regulation Section:Classification: | 21 CFR 862.1660, Quality Control MaterialClass I Reserved |
| Products Code: | JJX - Single (Specified) Analyte Controls (Assayed andUnassayed) |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device NamePredicate 510(k) No: | Elecsys HCG CalCheck 5K092168 |
| 4. Device Description: | ADVIA Centaur® ThCG Master Curve Materials is an in vitrodiagnostic product containing various levels of ThCG inlyophilized equine serum with preservatives includingamphotericin B. Each set contains ten lyophilized levels(MCM1-10); with a reconstituted volume of 1.0 mL each.MCM1 contains no analyte. The ThCG MCMs assigned valuesare lot specific of target values: 0.0, 5.00, 10.0, 25.0, 50.0, 100,250, 500, 750, and 1400 mIU/mL. |
| 5. Intended Use:Indication for Use: | See Indications for Use Statement below:The ADVIA Centaur® Total hCG (ThCG) Master Curve |
The ADVIA Centaur® Total hCG (ThCG) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay.
Section 006, Page 7 of 19
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| Special Conditions forUse Statement(s): | For prescription use only |
|---|---|
| Special InstrumentRequirements: | ADVIA Centaur® SystemsA description of the ADVIA Centaur system is documented inK971418. Subsequent modifications to the instrument havebeen reviewed and cleared in K032525 and K041133. |
| 6. Technological Characteristicsand Substantial Equivalence | A comparison of the device features, intended use, and otherinformation demonstrates that the ADVIA Centaur ThCG MCM |
-
- and Substantial Equivalence Comparison with Predicate:
er information demonstrates that the ADVIA Centaur ThCG MCM is substantially equivalent to the predicate device as summarized in Table 1.
- and Substantial Equivalence Comparison with Predicate:
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur ThCG MCM | Elecsys HCG CalCheck 5 |
| IntendedUse | The ADVIA Centaur Total hCG(ThCG) MCM is for in vitrodiagnostic use in the verification ofcalibration and reportable range ofthe ADVIA Centaur ThCG assay. | The Elecsys HCG CalCheck 5 is anassayed control for use in calibrationverification and for use in the verificationof the assay range established by theElecsys HCG+β reagent and ElecsysHCG STAT reagent on the indicatedElecsys and cobas e immunoassayanalyzers. |
| Analyte | HCG | Same |
| Use | Multiple Use | Same |
| Storage | 2-8°C | Same |
| Form | Lyophilized | Same |
| DIFFERENCES | ||
| Matrix | Equine Serum | Human Serum |
| Levels | 10 | 5 |
| Stability | Unopened - Stable when storedunopened at 2-8°C until the expirationdate on the vial label.Opened (Reconstituted) - Stablewhen stored at 2-8°C for 28 days; oron-board for 4 hours. | Unopened - Stable at 2-8°C up to theexpiration date printed on the bottlelabels.Opened (Reconstituted) - Stable for4 hours at 20-25°C. |
Table 1: Substantial Equivalence Comparison
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
-
- Standard/Guidance Document References
- The following recognized standard and guidance documents were used:
- CEN 13640 Stability Testing of In. Vitro Diagnostic Reagents .
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic . Calibrators
- Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control . Material
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration verification checks of the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
9. Performance Characteristics
9.1 Analytical performance:
The following studies are not applicable for the purpose of this submission:
- . Precision/Reproducibility
- Linearity/Assay Reportable Range .
- Detection limit .
- Analytical Specificity .
- Assay cut-off .
- Method Comparison Studies .
- Clinical Studies (Sensitivity, Specificity, and cut-off) .
9.2 Non-Clinical Performance Testing
9.2.1 Stability Studies
Stability studies were conducted to support the shelf life unopened and reconstituted material for the ADVIA Centaur ThCG MCMs to ensure that it maintains optimal product performance throughout the established shelf-life. The data supports the stability claims detailed in the ADVIA Centaur ThCG MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur ThCG MCM:
- Real Time/Shelf Life (unopened) .
- . In Use Open Vial (Reconstituted)
- . On-Board
Real time shelf-life studies (unopened): Test ThCG MCMs were stored unopened at 2-8℃ and tested at T=0 and at the following time points: 6 months, 12 months, and 15 months. Shelf life claims are based upon real time stability carried out one month after the duration claimed. Real time shelf-life stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the real-time stability study were met up to the 15 months' time point, which supports a shelf-life claim of 14 months. Unopened storage shelf-life is indicated by the expiration date on the vial label.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
In-Use Open Vial (Reconstituted): Test ThCG MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8°C, tested in 5 replicates per level at T=0, 7, 14, 21 28, and 29 days. Acceptance criteria for the open vial (reconstituted) stability study were met to the 29 days' time point, which supports the open vial claim of 28 days when properly stored at 2-8°C.
On-board Stability: Pooled aliquots of test ThCG MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T=0, 2, 4 and 5 hours. Acceptance criteria for the on-board stability study were met up to 5 hours. which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur ThCG MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be ● ≤ 2.0 mIU/mL dose; MCM2-3, the % dose recovery must be within 80 to 120%; MCM4-10, the % dose recovery must be within 85 to 115% calculated to Day 0 and/or no adverse trends.
- In-Use Open Vial (Reconstituted): The dose recovery for MCM1 must be . ≤ 2.0 mIU/mL dose; MCM2-3, versus -80℃ MCM2-3 the average dose % dose recovery must be within 80 to 120%; MCM4-10, versus -80℃ MCM4-10 the average dose % dose recovery must be within 85 to 115%.
- On-Board: The dose recovery for MCM1 must be ≤ 2.0 mIU/mL dose; . MCM2-3, the % dose recovery must be within 80 to 120%; MCM4-10, the % dose recovery must be within 85% to 115% calculated to Time=0.
9.2.2 Value Assignment
The ADVIA Centaur ThCG MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using hCG stock and are traceable to internal material which is standardized against World Health Organization (WHO) 4" IS 75/589 reference material. The MCMs are manufactured using qualified materials and measurement procedures.
For each new ThCG MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing run protocol is used for MCM2-MCM10 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-MCM10 were tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot. This protocol is designed to remove system and run variation. The new MCM doses must fall within the final value assignment specification for ThCG MCMs. The MCMs dose values are generated using the two-point calibration. The new MCM dose is calculated based on the relationship between the observed reference MCM dose and its assigned value. A performance verification run consisting of 6 replicates of each MCM level is run using one instrument, one reagent kit lot and Bio-Rad controls. The
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
mean MCM doses of the new MCM lot manufactured must fall within the customer range specifications.
The target for MCM1 is assigned a 0.0 dose. The quality control specifications and final value assignment limits for ThCG MCM ensure that MCM1 measures at or below the ThCG assay sensitivity limit. MCM10 targeted greater than the assay range is diluted with the MCM1 to meet the reportable range of the assay.
9.2.3 Expected Values
The expected values are the lot-specific assigned values obtained at value assignment and the lot-specific assigned ranges are the lot-specific customer ranges are determined per % interval as below.
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 35 |
| MCM3 | 25 |
| MCM4 | 25 |
| MCM5 | 25 |
| MCM6 | 25 |
| MCM7 | 25 |
| MCM8 | 25 |
| MCM9 | 25 |
| MCM10 | 25 |
Lot-specific assigned values and ranges are provided in the ADVIA Centaur ThCG MCM lot-specific value sheet in the example provided in Table 2.
| MCM Level | Target Values(mIU/mL) | Assigned Values(mIU/mL) |
|---|---|---|
| MCM1 | 0.00 | 0 |
| MCM2 | 5.00 | 4.39 |
| MCM3 | 10.0 | 9.82 |
| MCM4 | 25.0 | 21.5 |
| MCM5 | 50.0 | 45.0 |
| MCM6 | 100 | 94.3 |
| MCM7 | 250 | 270 |
| MCM8 | 500 | 557 |
| MCM9 | 750 | 791 |
| MCM10 | 1400 | 1393 |
| Assay Range | 2.0-1000 mIU/mL |
Table 2: Example Lot-specific ThCG MCM Target and Assigned Values
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
9.2.4 Traceability
The ADVIA Centaur ThCG assay is standardized against the WHO 4" IS 75/589 reference material. Assigned values for calibrators and MCMs are traceable to this standardization. The ThCG MCMs are manufactured using qualified materials and measurement procedures.
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur ThCG Master Curve Material (MCM) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys HCG CalCheck 5. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur ThCG Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
510(k) Summary - ADVIA Centaur TSTO Master Curve Material
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K140505
| 1. Applicant InformationMailing Address: | Siemens Healthcare Diagnostics Inc.511 Benedict AvenueTarrytown, NY 10591 USA |
|---|---|
| Contact Person: | Fatima Pacheco |
| Regulatory Clinical Affairs Specialist | |
| Phone Number: | (914) 524-2450 |
| Fax Number: | (914) 524-3579 |
| E-mail Address: | fatima.pacheco@siemens.com |
| Date Prepared: | February 24, 2014 |
| 2. Device Name | ADVIA Centaur® Testosterone (TSTO) Master Curve Material |
| Proprietary Name: | Quality Control materials for ADVIA Centaur TSTO assay |
| Measurand: | Master Curve Material (MCM) for ADVIA Centaur TSTO |
| Type of Test: | assay |
| Regulation Section: | 21 CFR 862.1660, Quality Control Material |
| Classification: | Class I Reserved |
| Products Code: | JJX - Single (Specified) Analyte Controls (Assayed and |
| Unassayed) | |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device Name | Elecsys Testosterone CalCheck |
| Predicate 510(k) No: | K970146 |
| 4. Device Description: | ADVIA Centaur® TSTO Master Curve Materials is an in vitrodiagnostic product containing various levels of testosterone |
spiked in lyophilized human plasma with sodium azide and preservatives. Each set contains seven lyophilized levels (MCM1-7); with a reconstituted volume of 1.0 mL each. MCMI contains no analyte. The TSTO MCMs assigned values are lot specific of target values 0.00, 50.0, 100, 500, 750, 1000, and 1600 ng/dL.
CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (HCV), and antibody
Section 006, Page 13 of 19
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
| ADVIA Centaur® VBI2, ThCG, and TSTO Master Curve Material (MCM) | |
|---|---|
| to HIV-1/2, all products manufactured using human sourcematerial should be handled as potentially infectious. Because notest method can offer complete assurance that hepatitis B or Cviruses, HIV, or other infectious agents are absent, theseproducts should be handled according to established goodlaboratory practices. | |
| 5. Intended Use: | See Indications for Use Statement below: |
| Indication for Use: | The ADVIA Centaur® Testosterone (TSTO) Master CurveMaterial is for in vitro diagnostic use in the verification ofcalibration and reportable range of the ADVIA CentaurTestosterone assay. |
| Special Conditions forUse Statement(s): | For prescription use only |
| Special Instrument | ADVIA Centaur® Systems |
| Requirements: | A description of the ADVIA Centaur system is documented inK971418. Subsequent modifications to the instrument havebeen reviewed and cleared in K032525 and K041133. |
| 6. Technological Characteristicsand Substantial EquivalenceComparison with Predicate: | A comparison of the device features, intended use, and otherinformation demonstrates that the ADVIA Centaur TSTO MCMis substantially equivalent to the predicate device assummarized in Table 1. |
,
.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
Table 1: Substantial Equivalence Comparison
| Table 1: Substantial Equivalence Comparison | ||
|---|---|---|
| SIMILARITIES | ||
| Candidate Device | Predicate Device | |
| Item | ADVIA Centaur TSTO MCM | Elecsys Testosterone CalCheck |
| IntendedUse | The ADVIA Centaur Testosterone(TSTO) MCM is for in vitrodiagnostic use in the verification ofcalibration and reportable range ofthe ADVIA Centaur TSTO assay. | For use in the verification of thecalibration established by the ElecsysTestosterone reagent on the indicatedElecsys and cobas e immunoassayanalyzers. |
| Analyte | Testosterone | Same |
| Use | Multiple Use | Same |
| Storage | 2–8°C | Same |
| Form | Lyophilized | Same |
| DIFFERENCES | ||
| Candidate Device | Predicate Device | |
| Matrix | Human Plasma | Human Serum |
| Levels | 7 | 3 |
| Stability | Unopened - Stable when storedunopened at 2-8°C until the expirationdate on the vial label.Opened (Reconstituted) - Stablewhen stored at 2-8°C for 14 days; oron-board for 4 hours. | Unopened - Stable at 2-8°C up to theexpiration date printed on the bottlelabels.Opened (Reconstituted) - Stable for4 hours at 15-25°C. |
7. Standard/Guidance Document References
The following recognized standard and guidance documents were used:
- CEN 13640 Stability Testing of In Vitro Diagnostic Reagents .
- Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic . Calibrators
- Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control . Material
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
8. Test Principle
The MCMs are specifically intended for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur assays for use on the ADVIA Centaur systems. Customers may use MCMs for bi-annual calibration verification checks of the assay range and linearity in order to meet the requirements of hospital accreditation bodies.
9. Performance Characteristics
9.1 Analytical performance:
The following studies are not applicable for the purpose of this submission:
- Precision/Reproducibility .
- Linearity/Assay Reportable Range .
- Detection limit .
- Analytical Specificity .
- Assay cut-off .
- . Method Comparison Studies
- . Clinical Studies (Sensitivity, Specificity, and cut-off)
9.2 Non-Clinical Performance Testing
9.2.1 Stability Studies
Stability studies were conducted to support the shelf life unopened and reconstituted material for the ADVIA Centaur TSTO MCMs to ensure that it maintains optimal product performance throughout the established shelf-life. The data supports the stability claims detailed in the ADVIA Centaur TSTO MCM Instructions for Use.
The following stability studies were performed for ADVIA Centaur TSTO MCM:
- . Real Time/Shelf Life (unopened)
- . In Use Open Vial (reconstituted)
- . On-Board
Real time shelf-life studies (unopened): Test TSTO MCMs were stored unopened at 2-8ºC and tested at T=0 and at the following time points: 12 months. 18 months, and 21 months. Shelf life claims are based upon real time stability carried out one month after the duration claimed. Real time shelf-life stability studies of MCMs were determined by comparison of dose recoveries to the T=0 dose recovery results. Acceptance criteria for the real-time stability study were met up to the 21 months' time point, which supports a shelf-life claim of 20 months. Unopened storage shelf-life is indicated by expiration date on the vial label.
In use open vial (reconstituted) stored at 2-88°C: Test TSTO MCMs were reconstituted, each level pooled, aliquotted and stored at 2-8℃, tested in 5 replicates per level at T=0, 2, 4, 7, 8, 11, 14 and 15 days. Acceptance criteria for the open vial (reconstituted) stability study were met up to the 15 day time point, which supports the open vial claim of 14 days when stored at 2-8°C.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
On-board Stability: Pooled aliquots of test TSTO MCMs in sample cups were stored on the ADVIA Centaur system and measured at time point T= 0, 2, 4 and 5 hours. Acceptance criteria for the on-board stability study were met up to 5 hours, which supports the on-board stability claim for 4 hours.
Stability Acceptance Criteria
The stability specifications acceptance criteria for the ADVIA Centaur TSTO MCM are as follows:
- Real Time/Shelf life (Unopened): The dose recovery for MCM1 must be . ≤ 10.0 ng/dL dose; MCM2-3, the average % dose recovery must be within 75 to 125%; MCM4-7, the average % dose recovery must be within 85 to 115% calculated to Day 0 and/or no adverse trends.
- . In Use Open Vial (reconstituted): The dose recovery for MCM1 versus fresh) v reconstituted -80℃ stored MCM1 average dose must be ≤ 10.0 ng/dL dose; for MCM2-3 versus freshly reconstituted -80°C stored MCM2-3 average dose, the average % dose recovery must be within 75 to 125%: MCM4-7 versus freshly reconstituted -80°C stored MCM4-7 average dose, the average % dose recovery must be within 85 to 115%.
- . On-Board: The dose recovery for MCM1 must be ≤ 10.0 ng/dL dose; MCM2-3, the % dose recovery must be within 75 to 125%; MCM4-7, the % dose recovery must be within 85 to 115% calculated to Time=0.
9.2.2 Value Assignment
The ADVIA Centaur TSTO MCMs are value assigned using assigned reference calibrators and MCMs. The assigned reference calibrators are prepared using USP (United States Pharmacopeia) testosterone stock and are traceable to analytically prepared internal material which are traceable to gas-chromatography-mass spectroscopy (GCMS). The MCMs are manufactured using qualified materials and measurement procedures.
For each new TSTO MCM lot manufactured, MCM1 is run in 5 replicates on two separate runs using one reagent kit lot. A nested testing run protocol is used for MCM2-MCM7 value assignment. This consists of running alternating samples of the reference and new MCM level in the same run. MCM2-MCM7 were tested on 20 replicates in total, comprised of one run and four sample cups run in 5 replicates on one system and one reagent kit lot. This protocol is designed to remove system and run variation. The new MCM doses must fall within the final value assignment specification for TSTO MCMs. The MCMs dose values are generated using the two-point calibration. The new MCM dose is calculated based on the relationship between the observed reference MCM dose and its assigned value. A performance verification run consisting of 6 replicates of each MCM level is run using one instrument, one reagent kit lot and Bio-Rad controls. The mean MCM doses of the new MCM lot manufactured must fall within the customer range specifications.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
The target for MCM1 is assigned a 0.0 dose. The quality control specifications and final value assignment limits for TSTO MCM ensure that MCM1 measures at or below the TSTO assay sensitivity limit. MCM7 targeted greater than the assay range is diluted with the MCM1 to meet the reportable range of the assay.
9.2.3 Expected Values
The expected values are the lot-specific assigned values obtained at value assignment and the lot-specific assigned ranges are the lot-specific customer ranges as determined per % interval as below.
| MCM Level | % Interval |
|---|---|
| MCM1 | N/A |
| MCM2 | 25 |
| MCM3 | 25 |
| MCM4 | 25 |
| MCM5 | 25 |
| MCM6 | 25 |
| MCM7 | 20 |
Lot-specific assigned values and ranges are provided in the ADVIA Centaur TSTO MCM lot-specific value sheet in the example provided in Table 2.
| MCM Level | Target Values(ng/dL) | Assigned Values(ng/dL) |
|---|---|---|
| MCM1 | 0 | 0.00 |
| MCM2 | 50.0 | 65.2 |
| MCM3 | 100 | 109 |
| MCM4 | 500 | 557 |
| MCM5 | 750 | 807 |
| MCM6 | 1000 | 1004 |
| MCM7 | 1600 | 1575 |
| Assay Range | 10-1500 ng/dL (0.35-52.1 nmol/L) |
Table 2: Example Lot-specific TSTO MCM Target and Assigned Values
9.2.4 Traceability
The ADVIA Centaur TSTO assay is traceable to an internal standard manufactured analytically which is traceable to gas chromatography-mass spectroscopy (GC-MS). The following equation describes the relationship between the testosterone standards and GCMS analysis throughout the assay range.
ADVIA Centaur Testosterone = 1.00 (GCMS) + 1.35 ng/dL, r = 1.00
Assigned values for calibrators and MCMs are traceable to this standardization. The TSTO MCMs are manufactured using qualified materials and measurement procedures.
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(Bundled) Abbreviated 510(k) Premarket Notification ADVIA Centaur® VB12, ThCG, and TSTO Master Curve Material (MCM)
10. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
11. Conclusion
The ADVIA Centaur TSTO Master Curve Material (MCM) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys Testosterone CalCheck. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur TSTO Maser Curve Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
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Image /page/19/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is centered horizontally. The words are all capitalized. The image is simple and contains no other elements.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2014
SIEMENS HEALTHCARE DIAGNOSTICS INC. FATIMA PACHECO 511 BENEDICT AVENUE TARRYTOWN NY 10591-5097
Re: K140505
Trade/Device Name: ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material ADVIA Centaur® Total Hcg (ThCG) Master Curve Material ADVIA Centaur® Testosterone (TSTO) Master Curve Material Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: February 24, 2014 Received: February 27, 2014
Dear Ms. Pacheco:
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 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. Pacheco
If you desire specific advice for your device on our labeling regulations (21 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/ResourcesforYou/Industry/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.
Courtney H. Lias -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140505
Device Name
ADVIA Centaur Vitamin B12 Master Curve Material, Total hCG Master Curve Material, and Testosterone Material
Indications for Use (Describe)
The ADVIA Centaur® Vitamin B12 (VB12) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur VB12 assay.
The ADVIA Centaur® Total hCG (ThCG) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur ThCG assay.
The ADVIA Centaur® Testosterone (TSTO) Master Curve Material is for in the verification of calibration and reportable range of the ADVIA Centaur Testosterone assay.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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§ 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.