(258 days)
The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.
The ADVIA Centaur iPTH reagent kit contains the following:
. ReadyPack® primary reagent pack containing ADVIA Centaur Lite and Solid Phase Reagent)
ADVIA Centaur iPTH Master Curve card .
Materials Required but Not Provided
iPTH Calibrator .
Optional Reagents
ADVIA Centaur Multi-Diluent 11 .
iPTH 1, 2, 3 quality control material .
iPTH Master Curve Material .
The Siemens ADVIA® Centaur Intact Parathyroid (iPTH) Assay is a quantitative in vitro diagnostic device used to measure intact parathyroid hormone (iPTH) in EDTA plasma or serum to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism. The device's performance was evaluated through studies on precision, interfering substances, cross-reactivity, and method comparison, demonstrating substantial equivalence to the predicate device, the Abbott Architect Intact PTH assay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were implicitly established by demonstrating comparability to the predicate device and meeting common analytical performance standards for in vitro diagnostic assays. The specific acceptance thresholds for each performance characteristic (e.g., %CV for precision, % bias for interference) are not explicitly stated as numbered criteria but are inferred from the reported results and the conclusion of substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Within-run and Total Imprecision should be acceptable for clinical use and comparable to predicate device performance. | Within Run %CV: Ranged from 2.6% (Medical Decision Pool 5, 1802.9 pg/mL and Control 3, 691.0 pg/mL) to 6.0% (Low Calibrator, 33.0 pg/mL).Total %CV: Ranged from 3.2% (Medical Decision Pool 5, 1802.9 pg/mL) to 9.2% (Patient Pool, 16.7 pg/mL). Overall, coefficients of variation were below 10%, indicating good precision. |
| Interfering Substances | Bias due to interferents (hemoglobin, bilirubin, triglycerides, biotin) should be < 10%. | Hemoglobin (up to 500 mg/dL): Bias ranged from -9.59% to -0.22%. At 200 mg/dL, bias ranged from -8.26% to -2.03%. All within < 10% effect.Bilirubin (unconjugated up to 40 mg/dL, conjugated up to 40 mg/dL): Bias ranged from -5.49% to 6.33%. All within < 10% effect.Triglycerides (up to 3000 mg/dL): Bias ranged from -3.75% to 7.14%. All within < 10% effect.Biotin (up to 0.10 mg/dL): Bias ranged from -3.35% to 7.54%. All within < 10% effect. |
| Cross-reactivity | Negligible cross-reactivity with related substances, or reported if significant. | PTH 1-34, PTH 39-68, PTH 39-84, PTH 44-68, PTH 53-84, Calcitonin, Beta-Cross Laps, Osteocalcin: Generally 0.00% cross-reactivity or negligible (e.g., -0.02% to 0.17%).PTH 7-84 fragment: Showed significant cross-reactivity of ~51% (50.74% in Multi-Dil 11 and 51.39% in Plasma Sample). This was noted for reporting in labeling. |
| Method Comparison | Good correlation with the predicate device (Abbott Architect Intact PTH assay), indicating substantial equivalence in results. | Correlation (y = ADVIA Centaur iPTH, x = Predicate): Based on 177 EDTA plasma samples, the regression equation was y = 1.03x - 3.32 with an R-value of 0.991 (using Least Squares Linear regression) and a mean (median) bias of -2.0% (-1.5%). This demonstrates strong correlation. |
| Matrix Equivalency | EDTA plasma and serum results should be highly correlated, indicating interchangeability. | Correlation (y = Serum, x = EDTA plasma): Based on 79 paired samples, the regression equation was 0.98x + 3.72 with an R-value of 0.992 (using Weighted Linear regression). This indicates that the two matrices are equivalent. |
| Expected Values | Reference ranges for plasma and serum should be established and comparable to clinically accepted values and predicate device. | Plasma: 13.8 to 85.0 pg/mL (1.46 to 9.01 pmol/L) for 95% of healthy donors.Serum: 12.4 to 76.8 pg/mL (1.31 to 8.14 pmol/L) for 95% of healthy donors. These values were established to confirm comparability to the predicate device and clinical norms. |
2. Sample Size and Data Provenance
- Precision:
- One patient EDTA plasma pool, five Medical Decision Pools (iPTH-spiked human EDTA plasma), two levels of calibrators, and three levels of commercial control materials.
- Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days.
- Total of 80 replicates per sample.
- Provenance: Not explicitly stated, but typically these studies are performed by the manufacturer, implying internal data collection. The use of "human EDTA plasma pools" suggests human-derived samples. These are likely prospective studies conducted for the purpose of regulatory submission.
- Interfering Substances:
- Three levels of PTH were evaluated for each interferent (Hemoglobin, Bilirubin, Triglycerides, Biotin).
- Provenance: Not explicitly stated, likely internal, prospective.
- Cross-reactivity:
- One normal EDTA plasma sample and an assay-specific Multi-diluent 11 (buffered goat serum with no analyte).
- Provenance: Not explicitly stated, likely internal, prospective.
- Method Comparison:
- Test Set Sample Size: 177 EDTA plasma samples.
- Data Provenance: Not explicitly stated, but typically collected internally for comparison against a predicate device, likely prospective for the purpose of the study.
- Serum Plasma Matrix Equivalency:
- Test Set Sample Size: 79 matched EDTA plasma and serum samples.
- Data Provenance: Not explicitly stated, likely internal, prospective.
- Expected Values:
- Matched serum and plasma samples from apparently healthy donors. Specific number not stated but usually involves a statistically significant cohort (e.g., >100 individuals) to establish a 95% reference range.
- Data Provenance: Not explicitly stated, but typically involves collecting samples from a healthy population, likely prospective.
3. Number of Experts and Qualifications
This submission pertains to an in vitro diagnostic assay, which relies on quantitative measurements rather than expert interpretation of images or clinical findings. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic imaging or clinical assessment is not applicable here. The ground truth is based on the chemical and immunological properties of the assay and comparison to a legally marketed predicate device.
4. Adjudication Method
Not applicable for an in vitro diagnostic assay like this. Adjudication methods are typically used in studies involving human interpretation or subjective assessments (e.g., by multiple readers).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic assay, not a device requiring human reader interpretation or assistance.
6. Standalone Performance
Yes, the studies described are for the standalone performance of the ADVIA Centaur iPTH assay (algorithm only, without human-in-the-loop performance in the sense of interpretative assistance). The performance metrics (precision, interference, cross-reactivity, method comparison) directly evaluate the assay's ability to accurately and reliably measure iPTH concentrations.
7. Type of Ground Truth Used
The ground truth for this device is established primarily by:
- Quantitative Chemical Measurement: The assay directly measures the concentration of intact parathyroid hormone using a chemiluminescent immunoassay. The "truth" is the actual concentration of iPTH in the samples.
- Comparison to a Predicate Device: For method comparison, the results from the legally marketed Abbott Architect Intact PTH assay (K063232) served as the reference or "ground truth" to establish substantial equivalence.
- Known Reference Standards/Spiked Samples: For precision and interference studies, the ground truth is often established by using clinically relevant pools with known or spiked analyte concentrations.
- Clinically Established Reference Ranges: Normal physiological ranges for iPTH from healthy donors are used to establish expected values.
8. Sample Size for the Training Set
The provided summary does not explicitly mention a "training set" in the context of machine learning or AI models. This device is a traditional immunoassay, which does not typically involve distinct training and test sets in the same way an AI/ML device would. The development (optimization and calibration) of the assay itself would involve numerous samples, but these are part of the assay's development and validation, not a formal "training set" as described in AI. The "testing" samples mentioned above are for performance validation for regulatory submission.
9. How the Ground Truth for the Training Set was Established
As noted above, the concept of a formal "training set" with established ground truth is not directly applicable to this traditional immunoassay. The development and optimization of such assays involve:
- Biochemical assays and calibration curves: These define the relationship between the signal detected (Relative Light Units) and the analyte concentration (iPTH). This is established using known iPTH standards.
- Cross-validation and optimization: During development, various reagents and parameters are tested and optimized using a wide range of samples to ensure robust and accurate performance across the assay's range.
- Reference materials and spiked samples: These are used to ensure the assay can accurately quantify iPTH across different concentrations and in the presence of potential interferences.
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510(k) Summary of Safety and Effectiveness for the
ADVIA® Centaur Intact Parathyroid (iPTH) Assay
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number: K/2198)
B. Date of Preparation: March 8, 2013
C. Proprietary and Established Names:
ADVIA® Centaur Intact Parathyroid Hormone (iPTH) Assay
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Philip Liu, Senior Manager, Regulatory Affairs and Compliance Office: (914) 524-2443 Fax: (914) 524-3579
E. Regulatory Information:
-
- Regulation section: 21 CFR § 862.1545
-
- Classification: Class II
-
- Product Code: CEW, Parathyroid Hormone Test System
-
- Panel: Clinical Chemistry
F. Predicate Device:
The ADVIA® Centaur iPTH Assay is substantially equivalent to the Abbott Architect Intact PTH Assay cleared under 510(k) K063232
G. Device Description:
The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.
The ADVIA Centaur iPTH reagent kit contains the following:
- . ReadyPack® primary reagent pack containing ADVIA Centaur Lite and Solid Phase Reagent)
- ADVIA Centaur iPTH Master Curve card .
Siemens Healthcare Diagnostics ADVIA Centaur iPTH Premarket Notification 510(k) March, 2013
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Materials Required but Not Provided
- iPTH Calibrator .
Optional Reagents
- ADVIA Centaur Multi-Diluent 11 .
- iPTH 1, 2, 3 quality control material .
- iPTH Master Curve Material .
H. Intended Use / Indications for Use:
The ADVIA Centaur iPTH assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
l. Substantial Equivalence Information:
Both the ADVIA Centaur iPTH assay (New Device) and Abbott Architect Intact PTH assay (Predicate Device cleared under K063232) employ prepackaged reagents for use on automated test systems. A comparison of the important similarities and differences of these assays is shown in the following tables:
Similarities:
| Item | New Device:ADVIA Centaur Intact PTHAssay | Predicate Device:Abbott Architect Intact PTH Assay |
|---|---|---|
| Intended Use | For in vitro diagnostic use in thequantitative determination ofintact parathyroid hormone (iPTH)in EDTA plasma or serum usingthe ADVIA Centaur systems | For in vitro chemiluminescentmicroparticle immunoassay (CMIA) forthe quantitative determination ofintact parathyroid hormone (PTH) inhuman serum and plasma on theARCHITECT i System |
| Indications forUse | This assay is intended to be usedto aid in the differential diagnosisof hyperparathyroidism andhypoparathyroidism. | In conjunction with serum calcium levels,this assay may be used as an aid in thedifferential diagnosis of hypercalcemia,hypocalcemia, or parathyroid disorders. |
| Sample type | EDTA Plasma, Serum | Serum and Plasma |
| Measurement | Quantitative | Same |
| OperatingPrinciple | Sandwich immunoassay | Same |
| Technology | Chemiluminescence | Same |
| DetectionAntibody | Goat polyclonal antibodyconjugated to Acridium Ester | Goat polyclonal antibody conjugated toAcridium |
| CaptureAntibody | Goat polyclonal antibodyconjugated to biotin directlycoupled to streptavidin magneticparticles | Goat polyclonal antibody coated tomicroparticles |
| Interference | No significant interference byhemolysis, icterus (bilirubin) | No significant interference fromhemoglobin, bilirubin, triglycerides or |
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| Item | New Device:ADVIA Centaur Intact PTH Assay | Predicate Device:Abbott Architect Intact PTH Assay |
|---|---|---|
| triglycerides, or biotin at testedlevels | protein at tested levels | |
| Expected Values | 13.8 - 85.0 pg/mL (plasma)12.4 - 76.8 pg/mL (serum) | 8.7 - 77.1 pg/mL |
| Calibration | 2 Point | 6 Point |
| Calibrators | Siemens iPTH Calibrators | ARCHITECT Intact PTH Calibrators |
| Number ofcalibrators | Two (2) levels | Six (6) levels |
| Use of Controls | Yes (recommended) | Same |
| Number ofcontrols | Three levels | Same |
| DetectionAntibody | Goat polyclonal antibodyconjugated to Acridium Ester | Same |
Differences:
| Item | New Device:ADVIA Centaur Intact PTHAssay | Predicate Device:Abbott Architect Intact PTH Assay |
|---|---|---|
| Assay Range | 5.5 – 1900 pg/mL | 3.0 – 3000 pg/mL (Routine)4.0 – 2500 pg/mL (STAT) |
| Sample Volume | 200 μL | 150 μL |
| Calibrators | Siemens iPTH Calibrators | ARCHITECT Intact PTH Calibrators |
| Calibration | 2 Point | 6 Point |
| Number ofcalibrators | Two (2) levels | Six (6) levels |
J. Test Principle
The ADVIA Centaur Intact PTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology. PTH in the sample reacts with the first antibody which is a polyclonal goat anti-human PTH (N-terminal 1-34) antibody labeled with acridinium ester. This complex is then captured by the solid phase (a second antibody which is a biotinylated polyclonal goat anti-human PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles). Unbound materials are then removed by washing. Acid Reagent and Base Reagent are then added to initiate the chemiluminescent reaction. A direct relationship exists between the amount of PTH present in the patient sample and the amount of relative light units (RLUs) detected by the system.
Siemens Healthcare Diagnostics ADVIA Centaur iPTH Premarket Notification 510(k) March, 2013
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K. Performance Characteristics
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, interfering and cross-reacting substances, and method comparison.
a. Precision
Precision estimates were computed according to CLSI document EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline. Within run and total imprecision were evaluated by testing one EDTA plasma (patient) pool, five (5) Medical Decision Pools (iPTH spiked into human EDTA plasma pools), two levels of calibrators, and 3 levels of commercial control materials. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days for a total of 80 replicates.
| Within Run | Total | |||||
|---|---|---|---|---|---|---|
| Sample | MEANpg/mL | SD | %CV | SD | %CV | |
| Patient Pool | 16.7 | 0.8 | 4.6 | 1.5 | 9.2 | |
| Low Calibrator | 33.0 | 2.0 | 6.0 | 2.3 | 6.9 | |
| Control 1 | 45.2 | 2.0 | 4.4 | 3.2 | 7.0 | |
| Medical Decision Pool 1 | 47.3 | 1.4 | 2.9 | 2.3 | 4.8 | |
| Medical Decision Pool 2 | 97.3 | 2.8 | 2.9 | 3.9 | 4.0 | |
| Medical Decision Pool 3 | 175.6 | 4.8 | 2.7 | 10.5 | 6.0 | |
| Control 2 | 196.6 | 6.8 | 3.5 | 8.3 | 4.2 | |
| Control 3 | 691.0 | 17.8 | 2.6 | 24.5 | 3.5 | |
| Medical Decision Pool 4 | 699.8 | 20.1 | 2.9 | 24.4 | 3.5 | |
| High Calibrator | 807.7 | 23.1 | 2.9 | 37.7 | 4.7 | |
| Medical Decision Pool 5 | 1802.9 | 46.7 | 2.6 | 57.7 | 3.2 |
b. Interfering Substances
Interference by hemoglobin, triglycerides (Intralipids), bilirubin, and biotin was evaluated in the ADVIA Centaur iPTH assay at three levels of PTH. There was no indication of interference (< 10% effect) up to the interferent levels claimed.
| Interferent | [Interf]mg/dL | Patient 1Dose(pg/mL) | Patient 1Bias (%) | Patient 2Dose(pg/mL) | Patient 2Bias (%) | Patient 3Dose(pg/mL) | Patient 3Bias (%) |
|---|---|---|---|---|---|---|---|
| Hemoglobin | 500 | 11.16 | -3.19% | 52.35 | -0.22% | 182.15 | -9.59% |
| 250 | 10.58 | -8.26% | 51.41 | -2.03% | 191.19 | -5.10% | |
| 0 | 11.53 | 52.47 | 201.48 | ||||
| Bilirubin(unconjugated) | 40 | 27.26 | 6.33% | 64.48 | -3.78% | 126.70 | -2.27% |
| 20 | 26.09 | 1.76% | 64.64 | -3.55% | 122.52 | -5.49% | |
| 0 | 25.64 | 67.02 | 129.64 | ||||
| Bilirubin(conjugated) | 40 | 25.29 | -7.19% | 64.49 | -2.85% | 116.18 | -3.72% |
| 20 | 26.35 | -3.32% | 62.57 | -5.75% | 116.28 | -3.64% | |
| 0 | 27.25 | 66.38 | 120.67 |
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Siemens Healthcare Diagnostics ADVIA Centaur iPTH
Premarket Notification 510(k) March, 2013
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| Interferent | [Interf] :mg/dL | Patient 1Dose(pg/mL) | Patient 1Bias (%) | Patient 2Dose(pg/mL) | Patient 2Bias (%) | Patient 3Dose(pg/mL) | Patient 3Blas (%) |
|---|---|---|---|---|---|---|---|
| Triglycerides | 3000 | 23.70 | 2.50% | 80.56 | 7.14% | 115.71 | 6.11% |
| 1500 | 22.34 | -3.38% | 72.37 | -3.75% | 111.29 | 2.06% | |
| 0 | 23.13 | 75.19 | 109.05 | ||||
| Biotin | 0.10 | 25.29 | 3.35% | 85.09 | 7.54% | 120.45 | -1.45% |
| 0.05 | 24.77 | 1.24% | 78.16 | -1.22% | 118.13 | -3.35% | |
| 0.00 | 24.47 | 79.12 | 122.23 |
c. Cross-reactivity
Cross reactivity was evaluated in the ADVIA Centaur iPTH immunoassay using a normal EDTA plasma sample and an assay specific Multi-diluent 11 (buffered goat serum with no analyte). No cross reactivity was observed at the highest levels tested with the exception of the PTH 7 - 84 fragment (~ 51%) - this will be reported in the Labeling.
| Protein | Interfipg/mL | Multi-Dil 11iPTH Dose(pg/mL) | %CrossReact. | PlasmaSampleiPTH Dose(pg/mL) | %CrossReact |
|---|---|---|---|---|---|
| PTH 1-34 | 300 | 0.00 | 0.00% | 45.17 | 0.09% |
| PTH 39-68 | 100,000 | 0.00 | 0.00% | 32.25 | -0.01% |
| PTH 39-84 | 100,000 | 0.42 | 0.00% | 26.23 | -0.02% |
| PTH 44-68 | 100,000 | 0.00 | 0.00% | 34.52 | -0.01% |
| PTH 53-84 | 100,000 | 1.32 | 0.00% | 29.61 | -0.02% |
| Calcitonin | 100,000 | 0.00 | 0.00% | 43.56 | 0.00% |
| PTH 7-84 | 300 | 152.21 | 50.74% | 203.70 | 51.39% |
| Beta-Cross Laps | 1000 | 0.00 | 0.00% | 33.44 | 0.17% |
| Osteocalcin | 50,000 | 0.00 | 0.00% | 32.67 | 0.00% |
d. Method Comparison
Method Comparison studies were done with EDTA plasma samples to demonstrate equivalence to the Predicate (Abbott Architect Intact PTH assay). The ADVIA Centaur iPTH assay shows good correlation in sample results compared to the Predicate.
| System (y) | N | RegressionEquation* | R** | Mean(Median)Bias (%) | Sample Range(pg/mL) |
|---|---|---|---|---|---|
| ADVIA Centaur iPTH(EDTA Plasma) | 177 | y = 1.03x - 3.32 | 0.991 | -2.0(-1.5) | 10.5 - 1882 |
x =Predicate (Abbott Architect Intact PTH assay)
- Passing & Bablok
** Least Squares Linear regression
e. Serum Plasma Matrix Equivalency
EDTA plasma and serum samples were compared in the ADVIA Centaur iPTH assay. Correlation results for EDTA plasma and serum demonstrate that the matrices are equivalent using the ADVIA Centaur iPTH assay.
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| N | RegressionEquation* | R | Sample Range(pg/mL) | |
|---|---|---|---|---|
| ADVIA Centaur iPTH | 79 | 0.98x + 3.72 | 0.992 | 11.1 - 1791 |
x = EDTA plasma, y = Serum
- Weighted Linear regression
f. Expected Values
Matched serum and plasma samples from apparently healthy donors were tested with the ADVIA Centaur iPTH to confirm that the Expected Values or reference range is comparable to the Predicate Device. The Expected Results (from 95% of the values) are:
For plasma: 13.8 to 85.0 pg/mL (1.46 to 9.01 pmol/L) For serum: 12.4 to 76.8 pg/mL (1.31 to 8.14 pmol/L)
L. Conclusions
Comparative testing of the ADVIA Centaur iPTH assay is substantially equivalent in principle and performance to the Predicate Device, Architect Intact PTH assay, cleared under 510(k) K063232.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 21, 2013
Siemens Healthcare Diagnostics c/o Philip Liu, Ph.D. 511 Benedict Avenue Tarrytown, New York 10591
Re: K121981
Trade/Device Name: ADVIA® Centaur Intact Parathyroid (iPTH) Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid Hormone Test System Regulatory Class: Class II Product Code: CEW Dated: February 14, 2013 Received: February 15, 2013
Dear Dr. Liu:
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. Ilsting 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 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 Part 801); 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 - Philip Liu
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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/cdrh/industry/support/index.html.
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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Indications for Use
510(k) Number (if known): K121981
Device Name:
ADVIA® Centaur Intact Parathyroid (iPTH) Assay
Indications for Use:
The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.
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. Chesleis-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K121981 510(k)
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.