(86 days)
Not Found
No
The description focuses on standard immunoassay technology and calibration methods, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) immunoassay intended for quantitative determination of calcitonin for diagnostic and treatment aid, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the calcitonin determination is "intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands."
No
The device description clearly outlines physical components like monoclonal antibodies, lyophilized products (CalSet, CalCheck 5, PreciControl Varia), and mentions use on "Elecsys and cobas e immunoassay analyzers," which are hardware instruments. This indicates it is a combination of reagents and likely software controlling the analyzers, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Elecsys Calcitonin Immunoassay is intended for "in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma." This is a key characteristic of an IVD, as it involves testing biological samples outside of the body.
- Purpose: The intended use also states that the determination is "intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands." This clearly indicates a medical purpose related to diagnosis and treatment, which is a core function of IVDs.
- Components: The description includes components like the immunoassay itself, calibrators (CalSet), and controls (CalCheck 5, PreciControl Varia). These are standard components of IVD test systems used for accurate and reliable results.
- Performance Studies: The document details performance studies such as precision, analytical sensitivity, and method comparison. These studies are required for IVDs to demonstrate their analytical performance and suitability for their intended use.
- Predicate Devices: The mention of predicate devices with K numbers (e.g., K023304 Siemens Immulite 1000 Calcitonin) indicates that this device is being compared to other legally marketed IVDs.
All of these factors strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Elecsys Calcitonin Immunoassay:
The Calcitonin Immunoasay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings.
Elecsys Calcitonin CalSet:
Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Elecsys and cobas e immunoassay analyzers.
Elecsys Calcitonin CalCheck 5:
The Elecsys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the calcitonin assay range established by the Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Varia:
The Elecsys PreciControl Varia is used for quality control of the Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JKR, JIT, JJY
Device Description
The Calcitonin Assay employs monoclonal antibodies specifically directed against hCT. The antibodies labeled with a ruthenium complex and biotin, respectively consist of mouse-specific components.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (K111506), with added calcitonin analyte.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: n = 150, Min = 2.04 pg/mL, Max = 1779 pg/mL
Passing/Bablok: Slope = 1.01, Intercept = -0.404, Tau/r = 0.925
Deming: Slope = 0.998, Intercept = -0.305, r = 0.991
Clinical Study/Reference Range: 97.5th percentile: Female 7.63 pg/mL, Male 14.3 pg/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measuring Range: 1.0 - 2000 pg/mL
Precision (Repeatability / Within-run):
- 0.03 SD @ 1.21 pg/mL
- 3.0% CV @ 11.5 pg/mL
- 2.5% CV @ 48.5 pg/mL
- 2.9% CV @ 482 pg/mL
- 2.2% CV @ 1910 pg/mL
- 0.19 SDPCV1 @ 8.88 pg/mL
- 1.5% CVPCV2 @ 97.7 pg/mL
Precision (Total / Intermediate):
- 0.04 SD @ 1.21 pg/mL
- 3.6% CV @ 11.5 pg/mL
- 3.5% CV @ 48.5 pg/mL
- 4.0% CV @ 482 pg/mL
- 3.4% CV @ 1910 pg/mL
- 0.26 SDPCV1 @ 8.88 pg/mL
- 2.6% CVPCV2 @ 97.7 pg/mL
Analytical Sensitivity:
- Limit of Blank (LoB): = 0.3 pg/mL
- Limit of Detection (LoD): = 0.5 pg/mL
- Limit of Quantitation (LoQ): = 1 pg/mL
Hook Effect: No high-dose hook effect at concentrations up to 1,000,000 pg/mL.
Limitations (unaffected by):
- Hemoglobin
§ 862.1140 Calcitonin test system.
(a)
Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).(b)
Classification. Class II.
0
Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics 9115 Hague Road Name, Address, P.O. Box 50416 DEC 0 4 2013 Indianapolis, IN 46250-0415 Contact Contact Person: Kelli Turner (Regulatory Affairs Principal) . Phone: (317) 521-4515 Fax: (317) 521-2324 o Email: kelli.turner@roche.com o Date Prepared: November 25, 2013 Device Name Proprietary name: (1) Elecsys Calcitonin Immunoassay (2) Elecsys Calcitonin CalSet (3) Elecsys Calcitonin CalCheck 5 (4) Elecsys PreciControl Varia Common name: (1) Calcitonin assay (2) Calcitonin CalSet (3) Calcitonin CalCheck 5 (4) PreciControl Varia Classification name: 1) Radioimmunoassay, Calcitonin 2) Calibrator, Secondary 3) Quality control material 4) Quality control material
1
| Device Name,
continued | Product Code: | 1) JKR
2) JIT
3) JJY
4) JJY |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device: | 1) Assay: Siemens Immulite 1000 Calcitonin,
Model LKCL (K023304)
2) Calibrator: Elecsys Vitamin D CalSet (K113546)
3) Control: Elecsys T4 CalCheck 5 (K112528)
4) Control: Elecsys PreciControl Varia (K111506) |
| Establishment
Registration | For the Elecsys Calcitonin test system, the establishment registration
number for Roche Diagnostics GmbH in Mannheim, Germany, is 9610126
and for Penzberg, Germany, is 9610529. The establishment registration
number for Roche Diagnostics in the United States is 1823260 | |
| Classification | The FDA has classified the Radiometry, Calcitonin test system and the
Calibrator, Secondary (Calcitonin CalSet) as a Class II device. The FDA has
classified the multi-analyte controls, all kinds (assayed and unassayed) as a
Class I device (Calcitonin CalCheck 5 and PreciControl Varia). | |
| Panel | Product
Code | Classification Name | Regulation Citation |
|--------------------|-----------------|---------------------------------|---------------------|
| Clinical Chemistry | JKR | Radioimmunoassay,
Calcitonin | 21 CFR 862.1140 |
| Clinical Chemistry | JIT | Calibrator, secondary | 21 CFR 862.1150 |
| Clinical Chemistry | JJY | Quality Control material | 21 CFR 862.1660 |
| Clinical Chemistry | JJY | Quality Control material | 21 CFR 862.1660 |
Analyzer Platform
For the analytical and clinical studies, the cobas e 411 was used as the master analyzer.
2
continued
The Calcitonin Assay employs monoclonal antibodies specifically directed Device against hCT. The antibodies labeled with a ruthenium complex and biotin, Description respectively consist of mouse-specific components.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (K111506), with added calcitonin analyte.
| Intended
Use/
Indications
for Use | Elecsys Calcitonin Reagent:
• The Calcitonin immunoassay is intended for the in vitro quantitative
determination of human calcitonin (thyrocalcitonin) in serum and
plasma. The calcitonin determination is intended to be used as an aid
in the diagnosis and treatment of diseases involving the thyroid and
parathyroid glands, including carcinoma and hyperparathyroidism in
conjunction with other clinical and laboratory findings.
The electrochemiluminescence immunoassay “ECLIA” is intended
for use on the indicated Elecsys and cobas e immunoassay analyzers. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Elecsys Calcitonin CalSet:
• Calcitonin CalSet is used for calibrating the quantitative Elecsys
Calcitonin assay on the Elecsys and cobas e immunoassay analyzers |
| | Elecsys Calcitonin CalCheck 5:
• The Elecsys Calcitonin CalCheck 5 is an assayed control for use in
calcitonin calibration verification and for use in the verification of
the calcitonin assay range established by the Elecsys and cobas e
immunoassay analyzers. |
| | Elecsys PreciControl Varia:
• The Elecsys PreciControl Varia is used for quality control of the
Elecsys immunoassays on Elecsys and cobas e immunoassay
analyzers. |
3
510(k) Summary for Calcitonin test system, continued
Substantial The Elecsys Calcitonin Test System is substantially equivalent to other devices legally marketed in the United States. Equivalence
The Elecsys Calcitonin immunoassay is equivalent to Immulite 1000 Calcitonin (K023304).
Elecsys Calcitonin CalSet is equivalent to Elecsys Vitamin D CalSet (K113546).
Elecsys Calcitonin CalCheck 5 is equivalent to the Elecsys T4 CalCheck 5 (K112528).
Elecsys PreciControl Varia is equivalent to Elecsys PreciControl Varia (K111506).
Substantial Equivalence -Comparison
The following tables compare:
- . The Elecsys Calcitonin Immunoassay with its predicate device (K023304).
- . The Calcitonin CalSet with its predicate device (K113546).
- The Calcitonin CalCheck 5 its the predicate device (K112528). .
- PreciControl Varia to its predicate device (K111506). .
4
Comparison of Assays, Similarities and Differences
Table 1
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Immulite 1000 | |
| Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay | |
| Intended | ||
| Use/ | ||
| Indications | ||
| for Use | Intended to measure the thyroid | |
| hormone calcitonin (thryocalcitonin) | ||
| levels in serum. Calcitonin | ||
| measurements are used in the | ||
| diagnosis and treatment of diseases | ||
| involving the thyroid and parathyroid | ||
| glands, including carcinoma and | ||
| hyperparathyroidism (excessive | ||
| activity of the parathyroid gland). | The Calcitonin immunoassay is | |
| intended for the in vitro quantitative | ||
| determination of human calcitonin | ||
| (thyrocalcitonin) in serum and plasma. | ||
| The calcitonin determination is | ||
| intended to be used as an aid in the | ||
| diagnosis and treatment of diseases | ||
| involving the thyroid and parathyroid | ||
| glands, including carcinoma and | ||
| hyperparathyroidism in conjunction | ||
| with other clinical and laboratory | ||
| findings. | ||
| The electrochemiluminescence | ||
| immunoassay "ECLIA" is intended | ||
| for use on the indicated Elecsys and | ||
| cobas e immunoassay analyzers. | ||
| Assay | ||
| Protocol | A solid-phase, enzyme-labeled, two- | |
| site chemiluminescent immunometric | ||
| assay. The solid-phase, a polystyrene | ||
| bead enclosed within an IMMULITE | ||
| 1000 Test Unit, is coated with a | ||
| monoclonal murine antibody specific | ||
| for calcitonin. | ||
| Incubation cycles: 2 x 30 minutes | ||
| Total duration of assay: 60 minutes. | Assay employs murine monoclonal | |
| antibodies specifically directed against | ||
| hCT. One antibody is labeled with | ||
| ruthenium complex; the second | ||
| antibody is labeled with Biotin. | ||
| Streptavidin coated microparticles are | ||
| used as solid phase. | ||
| Sandwich principle. Total duration of | ||
| assay: 18 minutes | ||
| Detection | ||
| Protocol | Chemiluminescent Immunometric | |
| assay | Electrochemiluminescent | |
| Immunoassay | ||
| Applications | 60-minute application | 18-minute application |
| Assay Comparison | ||
| Feature | Predicate Device: Immulite 1000 | |
| Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay | |
| General Assay Features | ||
| Instrument | ||
| Platform | Immulite 1000 | cobas e 411 |
| Sample | ||
| Volume | 75 µL | 50 µL |
| Sample | ||
| Type | Human serum or heparinized plasma | Human serum and plasma treated with |
| K2-EDTA, K3-EDTA, lithium heparin | ||
| and lithium heparin plasma gel | ||
| separation tubes. | ||
| Reagents | A solid-phase, enzyme-labeled, two- | |
| site chemiluminescent immunometric | ||
| assay. The solid-phase, a polystyrene | ||
| bead enclosed within an IMMULITE | ||
| 1000 Test Unit, is coated with a | ||
| monoclonal murine antibody specific | ||
| for calcitonin. | ||
| Incubation cycles: 2 x 30 minutes | ||
| Total duration of assay: 60 minutes. | Sandwich principle. Total duration of | |
| assay: 18 minutes | ||
| Assay employs murine monoclonal | ||
| antibodies specifically directed against | ||
| hCT. One antibody is labeled with | ||
| ruthenium complex; the second | ||
| antibody is labeled with Biotin. | ||
| Streptavidin coated microparticles are | ||
| used as solid phase. | ||
| Calibrator | Siemens Calcitonin Adjustors (LCLL, | |
| LCLH) | Elecsys Calcitonin CalSet |
5
Comparison of Assays-Similarities and Differences, continued
Table 1 continued
6
510(k) Summary for Elecsys Calcitonin, continued
Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Immulite 1000 | |
| Calcitonin, Model LKCL | ||
| (K023304) | Elecsys Calcitonin Immunoassay | |
| General Assay Features | ||
| Calibration | ||
| Interval | Recommended Adjustment interval: | |
| 4 weeks | Calibration must be performed once | |
| per reagent lot using fresh reagent (i.e. | ||
| not more than 24 hours since the | ||
| reagent kit was registered on the | ||
| analyzer). Renewed calibration is | ||
| recommended as follows: | ||
| cobas e 411 analyzers: | ||
| After 2 months (56 days) when | ||
| using the same reagent lot. | ||
| After 7 days (when using the | ||
| same reagent kit on the | ||
| analyzer). | ||
| As required: e.g. quality control | ||
| findings outside the specified limits | ||
| Controls | Use controls or sample pools with at | |
| least two levels (low and high) of | ||
| calcitonin. | Elecsys PreciControl Varia | |
| Traceability / | ||
| Standardizati | ||
| on | Standardized against WHO 2nd IRP | |
| 89/620 | Same | |
| Reagent | ||
| Stability | Stable at 2-8°C until expiration date | Unopened: |
| 2-8°C - Up to the stated expiration | ||
| date | ||
| Opened 2-8°C - 12 weeks | ||
| On Analyzers - 4 weeks |
7
510(k) Summary for Elecsys Calcitonin, continued
Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Assay Comparison | |||||
|---|---|---|---|---|---|
| Feature | Predicate Device: Immulite 1000 | ||||
| Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay | ||||
| Labeled Performance Characteristics | |||||
| Measuring | |||||
| Range | 0.6 - 2000 pg/mL | 1.0 - 2000 pg/mL | |||
| Precision | Within-run | ||||
| Sample | Mean | SD | CV | cobas e 411: | |
| Within-run (will be labeled Repeatability) | |||||
| 1 | 22 | 0.86 | 3.9% | 0.03 SD @ 1.21 pg/mL | |
| 2 | 44 | 1.3 | 3.0% | 3.0% CV @ 11.5 pg/mL | |
| 3 | 145 | 3.3 | 2.3% | 2.5% CV @ 48.5pg/mL | |
| 4 | 621 | 13.8 | 2.2% | 2.9% CV @ 482 pg/mL | |
| 5 | 1029 | 24.8 | 2.4% | 2.2% CV @ 1910 pg/mL | |
| 6 | 1207 | 27.4 | 2.3% | 0.19 SDPCV1 @ 8.88 pg/mL | |
| 1.5% CVPCV2 @ 97.7 pg/mL | |||||
| Total | |||||
| Sample | Mean | SD | CV | Total (will be labeled Intermediate) | |
| 1 | 22 | 2.5 | 11.4% | 0.04 SD @ 1.21 pg/mL | |
| 2 | 44 | 3.3 | 7.5% | 3.6% CV @ 11.5 pg/mL | |
| 3 | 145 | 10.9 | 7.5% | 3.5% CV @ 48.5pg/mL | |
| 4 | 621 | 65.6 | 10.6% | 4.0% CV @ 482 pg/mL | |
| 5 | 1029 | 87.3 | 8.5% | 3.4% CV @ 1910 pg/mL | |
| 6 | 1207 | 115 | 9.5% | 0.26 SDPCV1 @ 8.88 pg/mL | |
| 2.6% CVPCV2 @ 97.7 pg/mL |
PCV2=PreciControl Varia level 2
8
Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Immulite 1000 | |
| Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay | |
| Labeled Performance Characteristics | ||
| Analytical | ||
| Sensitivity | 2 pg/mL | Limit of Blank (LoB): = 0.3 pg/mL |
| Limit of Detection (LoD): = 0.5 | ||
| pg/mL | ||
| Limit of Quantitation (LoQ): = 1 | ||
| pg/mL | ||
| Hook Effect | There is no high-dose hook effect at | |
| concentrations up to 25,000 pg/mL. | There is no high-dose hook effect at | |
| concentrations up to 1,000,000 pg/mL. | ||
| Limitations | The assay is unaffected by the presence of: | |
| ● Hemoglobin |