(177 days)
The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy.
The ARCHITECT Cyclosporine Calibration are for the ARCHITECT i System when used for the quantitative determination of cyclosporine in human whole blood.
The ARCHITECT Cyclosporine Whole Blood Precipitation Reagent is for the extraction of cyclosporine from samples (human whole blood patient specimens, controls, and ARCHITECT Cyclosporine Calibrators) to be tested on the ARCHITECT i System.
The ARCHITECT Cyclosporine assay is a two-step immunoassay for the quantitative determination of cyclosporine in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex.
Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is lysed with a solubilization reagent, extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System.
In the first step, sample, assay diluent, and anti-cyclosporine coated paramagnetic microparticles are combined to create a reaction mixture. Cyclosprorine present in the sample binds to the anti-cyclosporine coated microparticles. After washing, cyclosporine acridiniumlabeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of cyclosporine in the sample and the RLUs detected by the ARCHITECT i System optics.
Here's a breakdown of the acceptance criteria and the studies performed for the ARCHITECT Cyclosporine Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for precision, linearity, functional sensitivity, or analytical sensitivity in numerical terms (e.g., "Precision must be <= 10% CV"). Instead, it reports the determined performance characteristics. However, for the substantial equivalence study, implicit acceptance is based on strong correlation and a reasonable intercept/slope compared to the predicate and LC/MS/MS.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Strong correlation, slope close to 1, intercept close to 0 when compared to predicate device and LC/MS/MS. | vs. TDx/TDxFLx (Predicate):Correlation: 0.99Intercept: -24.65 (95% CI: -32.54 to -19.99)Slope: 0.93 (95% CI: 0.91 to 0.95)vs. LC/MS/MS:Correlation: 0.99Intercept: -24.94 (95% CI: -32.71 to -19.18)Slope: 1.20 (95% CI: 1.17 to 1.23) |
| Precision (%CV) | Acceptable precision for clinical use (often defined by CLSI guidelines, e.g., <15% for therapeutic drug monitoring). | Total precision was determined to be less than or equal to 15%. |
| Linearity (Mean Recovery) | Mean recovery within a specified percentage of the expected result (e.g., +/- 10%). | Mean recovery within 10% of the expected result for diluted samples. |
| Functional Sensitivity | Lowest concentration with a 20% CV at the upper 95% confidence limit. | 20.7 ng/mL. |
| Analytical Sensitivity | Limit of detection at 95% confidence. | 4.7 ng/mL. |
| Interference (Average Recovery) | Average recovery within a specific range (e.g., 90-110%) when interfering substances are present. | Average recovery 97 to 108%. |
| Specificity (% Cross Reactivity) | Low percentage of cross-reactivity with known metabolites. | AM1: 0.1%, AM1c: 1.0%, AM4N: -0.6%, AM9: -0.2%, AM19: -0.4%. |
2. Sample Sizes and Data Provenance
Substantial Equivalence Study:
- Sample Size (Test Set): 227 observations (human whole blood specimens).
- Data Provenance: Human whole blood specimens from heart, renal, and liver transplant patients receiving cyclosporine therapy. This indicates prospective or retrospective clinical samples, primarily from a clinical setting. The country of origin is not specified.
Precision Study:
- Sample Size (Test Set): Not explicitly stated as a single number for a "test set." Instead:
- 3 levels of Abbott Immunosuppressant-MCC (levels 1, 3, and 4)
- 2 pooled patient samples
- 3 human whole blood samples spiked with cyclosporine
- "two lots of reagents, on two instruments, in replicates of two at two separate times per day for 20 days."
- Data Provenance: Clinical samples (pooled patient samples, spiked human whole blood). Country of origin not specified.
Linearity Study:
- Sample Size (Test Set): High concentration cyclosporine whole blood specimens (number not specified) used to create dilutions.
- Data Provenance: Clinical samples (high concentration cyclosporine whole blood specimens). Country of origin not specified.
Functional Sensitivity Study:
- Sample Size (Test Set): Whole blood specimens spiked with cyclosporine (number not specified) "tested in replicates of 10, twice a day, for five days."
- Data Provenance: Spiked whole blood specimens. Country of origin not specified.
Analytical Sensitivity Study:
- Sample Size (Test Set): n=24 runs, 10 replicates for calibrator A, and 4 replicates for calibrator B per run.
- Data Provenance: Calibrator materials. Country of origin not specified.
Interference Study:
- Sample Size (Test Set): Whole blood specimens (number not specified) supplemented with various drugs and potential interfering compounds.
- Data Provenance: Clinical samples (whole blood specimens). Country of origin not specified.
Specificity Study:
- Sample Size (Test Set): 5 whole blood specimens augmented with cyclosporine and spiked with cross-reactant solutions.
- Data Provenance: Clinical samples (whole blood specimens). Country of origin not specified.
3. Number of Experts and Qualifications for Ground Truth
- The document describes analytical performance studies and equivalence to a predicate device and LC/MS/MS, not a diagnostic imaging or pathology study requiring human expert consensus for "ground truth" in the traditional sense.
- For the "ground truth" in the substantial equivalence study: The predicate device (ABBOTT TDx/TDxFLx Cyclosporine Monoclonal Whole Blood) and LC/MS/MS are considered the reference methods. The performance of these reference methods themselves serves as the "ground truth." There is no mention of human experts establishing ground truth for these analytical measurements.
4. Adjudication Method for the Test Set
- Not applicable. This is an in-vitro diagnostic device measuring an analyte concentration, not a study requiring human adjudication of diagnostic findings. The "adjudication" is done by comparing the device's output to the output of established reference methods (predicate device and LC/MS/MS).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is typically for evaluating diagnostic imaging or screening devices where human readers interpret cases. This submission is for an in-vitro diagnostic assay for quantitative measurement of cyclosporine.
6. Standalone Performance Study (Algorithm Only)
- Yes, implicitly. All the performance characteristic studies (precision, linearity, functional sensitivity, analytical sensitivity, interference, specificity) and the substantial equivalence study (comparison to predicate and LC/MS/MS) represent the standalone performance of the ARCHITECT Cyclosporine Assay without human intervention in the measurement process itself, beyond sample preparation and loading onto the automated instrument. The device is intended to be automated.
7. Type of Ground Truth Used
-
Substantial Equivalence Study: The ground truth was established by comparison to:
- Predicate Device: ABBOTT TDx/TDxFLx Cyclosporine Monoclonal Whole Blood assay. This is an existing, legally marketed diagnostic device.
- Reference Method: LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and precise analytical technique, often considered a "gold standard" for quantitative measurements of many analytes in clinical chemistry.
-
Other Performance Studies (Precision, Linearity, etc.): The ground truth was established by statistical analysis of repeat measurements, dilutions with known concentrations, or spiked samples with known concentrations.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning. The studies described are performance validation studies for an immunoassay. The device calculates results based on a calibrator curve.
- Calibrator Curve: The assay uses 6 levels of calibrators (0 - 1500 ng/mL) to establish the calibration curve. This is analogous to a very small "training set" for the instrument to learn the relationship between RLU signal and cyclosporine concentration.
9. How the Ground Truth for the Training Set (Calibrator Curve) was Established
- The ground truth for the calibrator curve is established by using pre-defined calibrator materials with known concentrations of cyclosporine. These calibrators are typically manufactured to precise specifications.
- The document states: "The ARCHITECT Cyclosporine Calibrators are for the calibration of the ARCHITECT i System..." and "Calibrators: 6 Levels (0 - 1500 ng/mL)" with a "Processed human whole blood" matrix.
- The known concentrations of these calibrators are used to generate the standard curve against which unknown patient samples are then measured.
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510(k) SUMMARY
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.
The assigned 510(k) number is:4080751
Submitter Information
| Address: | Fujirebio Diagnostics, Inc.201 Great Valley ParkwayMalvern, PA 19355 |
|---|---|
| Contact person: | Stacey Moll(610) 240-3843molls@fdi.com |
| Summary preparation date: | March 10, 2008 |
Name of Device
| Trade/Proprietary Name: | ARCHITECT Cyclosporine AssayARCHITECT Cyclosporine Calibrators |
|---|---|
| Common/Usual Name: | Cyclosporine Test SystemsCalibrator |
| Regulation Number: | 21 CFR 862.123521 CFR 862.3200 |
| Regulatory Class: | Class II |
| Product Code: | MKWDLJ |
Predicate Device
ABBOTT TDx/TDxFLx Cyclosporine Monoclonal Whole Blood (P8900251 and supplement 7)
Device Description
The ARCHITECT Cyclosporine assay is a two-step immunoassay for the quantitative determination of cyclosporine in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex.
'note: cyclosporine test systems have been reclassified into Class II since the predicate was approved
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Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is lysed with a solubilization reagent, extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System.
In the first step, sample, assay diluent, and anti-cyclosporine coated paramagnetic microparticles are combined to create a reaction mixture. Cyclosprorine present in the sample binds to the anti-cyclosporine coated microparticles. After washing, cyclosporine acridiniumlabeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of cyclosporine in the sample and the RLUs detected by the ARCHITECT i System optics.
Intended Use
Reagent Kit
The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy.
Calibrator Kit
The ARCHITECT Cyclosporine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cyclosporine in human whole blood.
Whole Blood Precipitation Reagent Kit
The ARCHITECT Cyclosporine Whole Blood Precipitation Reagent is for the extraction of cyclosporine from samples (human whole blood patient specimens, controls, and ARCHITECT Cyclosporine Calibrators) to be tested on the ARCHITECT i System.
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Statement of Substantial Equivalence
The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.
The ARCHITECT Cyclosporine assay is substantially equivalent to the TDxTDxFLx Cyclosporine Monoclonal Whole Blood assay. Both of the devices are IVD products and are indicated for the quantitative determination of cyclosporine in human whole blood and used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.
A study was performed using human whole blood specimens from heart, renal and liver transplant patients receiving cyclosporine therapy, where regression analysis was performed using the Passing-Bablok method. Data from the study are summarized in the following table.
| ARCHITECT Cyclosporine vs. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood | |||
|---|---|---|---|
| Number ofObservations | Intercept(95% CIa) | Slope(95% CI) | CorrelationCoefficient |
| 227 | -24.65(-32.54 to -19.99) | 0.93(0.91 to 0.95) | 0.99 |
a Confidence Interval
Specimen Range (ARCHITECT): 31.3 ng/mL to 1457.3 ng/mL Specimen Range (TDx): 44.99 ng/mL to 1457.3 ng/mL
Additional testing of the above sample was completed with LC/MS/MS, where regression analysis was performed using the Passing-Bablok® method. Data from the study are summarized in the following table.
| ARCHITECT Cyclosporine vs. LC/MS/MS | |||
|---|---|---|---|
| Number ofObservations | Intercept(95% Cl) | Slope(95% CI) | CorrelationCoefficient |
| 227 | -24.94(-32.71 to -19.18) | 1.20(1.17 to 1.23) | 0.99 |
Specimen Range (ARCHITECT): 31.3 ng/mL to 1457.3 ng/mL Specimen Range (LC/MS/MS): 31.3 ng/mL to 1220 ng/mL
2 Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from two different analytical methods. J Clin Chem Clin Biochem 1983; 21(11)709-20.
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A comparison of the features of the ARCHITECT Cyclosporine assay and the TDx/TDxFLx Cyclosporine Monoclonal Whole Blood assay are as follows:
| Similarities | ||
|---|---|---|
| ARCHITECT Cyclosporine(Proposed Device) | TDx/TDxFLx CyclosporineMonoclonal Whole Blood(Predicate Device)P8900253 and supplement 7 | |
| Device Type | In vitro diagnostic | In vitro diagnostic |
| CFR section | 862.1235 | 862.1235 |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | Quantitative determination ofcyclosporine in human wholeblood as an aid in themanagement of heart, liver andkidney transplant patientsreceiving cyclosporine therapy. | Quantitative determination ofcyclosporine in human wholeblood as an aid in themanagement of heart, liver andkidney transplant patientsreceiving cyclosporine therapy. |
| Type of Specimen | Human Whole Blood | Human Whole Blood |
| Specimen PretreatmentStep | Manual extraction of cyclosporinein human whole blood | Manual extraction of cyclosporinein human whole blood |
| Calibrators | 6 Levels (0 - 1500 ng/mL) | 6 Levels (0 - 1500 ng/mL) |
| Calibrator Matrix | Processed human whole blood | Processed human whole blood |
| Antibody | Mouse monoclonal (anti -cyclosporine) | Mouse monoclonal (anti -cyclosporine) |
| Interpretation of Results | Calibrator Curve | Calibrator Curve |
| Precipitation Reagent | Zinc sulfate solution in methanoland ethylene glycol. | Zinc sulfate solution in methanoland ethylene glycol |
| Solubilization Reagent | Surfactants in water | Surfactants in water |
| Differences | ||
|---|---|---|
| ARCHITECT Cyclosporine(Proposed Device) | TDx/TDxFLx CyclosporineMonoclonal Whole Blood(Predicate Device)P890025⁴ and supplement 7 | |
| Instrument System | ARCHITECT System | TDx/TDxFLx System |
| Principle of Operation | Chemiluminscent MicroparticleImmunoassay (CMIA) | Fluorescence PolarizationImmunoassay (FPIA) |
| Detection | Cyclosporine acridinium-labeledconjugate in citrate buffer withdetergent | <0.01% fluorescein tracer in buffercontaining surfactant and proteinstabilizer. |
| Capture | Anti-cyclosporine (mouse,monoclonal) coated paramagnetic | <25% Antibody (mousemonoclonal) in buffer with protein |
3note: cyclosporine test systems have been reclassified into Class II since the predicate was approved
4note: cyclosporine test systems have been reclassified into Class II since the predicate was approved
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| microparticles in MOPS buffer withprotein stabilizers. | stabilizer. | |
|---|---|---|
| Classification andProduct Code | Class II, MKW | Class II, MGU |
| Specimen CollectionMethod | EDTA Whole Blood CollectionTubes | EDTA and Heparin Whole BloodCollection Tubes |
Performance Characteristics
Precision:
A study was performed with the ARCHITECT Cyclosporine assay based on quidance from the Clinical and Laboratory Standards Institute, document (CLSI, formerly NCCLS) Protocol EP5-A2. Abbott Immunosuppressant-MCC (levels 1, 3, and 4) and two pooled patient samples and 3 human whole blood samples spiked with cyclosporine were assaved, using two lots of reagents. on two instruments, in replicates of two at two separate times per day for 20 days. Each reagent lot used a single calibration curve throughout the study.
The total precision %CV of the ARCHITECT Cyclosporine assay was determined to be less than or equal to 15%.
Linearity:
A dilution linearity study was performed by diluting high concentration cyclosporine whole blood specimens with the ARCHITECT Cyclosporine Calibrator A. The concentration of cyclosporine was determined for each dilution of sample and the mean percent (%) recovery was calculated.
The ARCHITECT Cvclosporine assay was determined to have a mean recovery within 10% of the expected result for diluted samples.
Functional Sensitivity:
Whole blood specimens were spiked with cvclosporine to achieve approximate concentrations from 5 to 50 ng/mL and tested in replicates of 10, twice a day, for five days. At the upper 95% confidence limit, the lowest ARCHITECT Cyclosporine assay value exhibiting a 20% CV was calculated to be 20.7 ng/mL.
Analytical Sensitivity:
The limit of detection for the ARCHITECT Cyclosporine assay, defined as the concentration at two standard deviations above the ARCHITECT Cyclosporine Calibrator A (0.0 ng/mL) was calculated to be 4.7 ng/mL at the 95% confidence (based on one study with n=24 runs, 10 replicates calibrator A and 4 replicates calibrator B per run).
Interference:
Whole blood specimens were supplemented with various drugs and potentially interfering compounds (triglycerides, hematocrit, bilirubin, total protein, cholesterol, uric acid, HAMA, and
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rheumatoid factor [RF]). The average recovery observed during the study ranged from 97 to 108%.
Specificity:
Aliquots of whole blood specimens were augmented with cyclosporine, targeting values ranging from 30 to 1500 ng/mL. These five specimens were spiked with cross-reactant solution. Data from this study are summarized in the following table.
| Metabolite | AmountAdded(ng/mL) | Mean ExcessConcentrationDetected(ng/mL, n=5) | % CrossReactivitya |
|---|---|---|---|
| AM1 | 1000 | 0.7 | 0.1 |
| AM1c | 1000 | 10.2 | 1.0 |
| AM4N | 1000 | -5.9 | -0.6 |
| AM9 | 1000 | -1.6 | -0.2 |
| AM19 | 1000 | -4.5 | -0.4 |
a Cross-reactivities as estimated by interference with the measurement of Cyclosporine in whole blood specimens.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2008
Fujirebio Diagnostics, Inc. c/o Ms. Stacey Moll Regulatory Affairs Specialist 201 Great Valley Pkwy. Malvern, PA 19355
Re: K080751
Trade Name: Architect Cyclosporine Assay Regulation Number: 21 CFR 862. 1235 Regulation Name: Cyclosporine Test System Regulatory Class: Class II Product Codes: MKW, DLJ Dated: August 25, 2008 Received: August 26, 2008
Dear Ms. Moll:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 108075
Device Name: ARCHITECT Cyclosporine
Indications For Use:
Reagent Kit
The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy,
Calibrator Kit
The ARCHITECT Cyclosporine Calibration are for the ARCHITECT i System when used for the quantitative determination of cyclosporine in human whole blood.
Whole Blood Precipitation Reagent Kit
The ARCHITECT Cyclosporine Whole Blood Precipitation Reagent is for the extraction of cyclosporine from samples (human whole blood patient specimens, controls, and ARCHITECT Cyclosporine Calibrators) to be tested on the ARCHITECT i System.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K080751
§ 862.1235 Cyclosporine test system.
(a)
Identification. A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.