(177 days)
P8900251, P8900253
Not Found
No
The document describes a standard immunoassay technology and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) assay designed to quantify cyclosporine levels in human whole blood. While it aids in managing patients receiving cyclosporine therapy, it does not directly administer therapy, treat, or prevent disease, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states: "The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy." This explicitly indicates its role in patient management, which is a diagnostic purpose.
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) that involves physical reagents, manual sample preparation steps (lysis, extraction, centrifugation, decanting), and measurement of relative light units (RLUs) by the ARCHITECT i System optics. This is a hardware-based in vitro diagnostic device, 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 assay is for the "quantitative determination of cyclosporine in human whole blood". This is a diagnostic measurement performed on a biological sample (whole blood) taken from the human body.
- Purpose: The assay is used "as an aid in the management of heart, liver, and kidney transplant patients receiving cyclosporine therapy." This indicates that the results are used to inform clinical decisions regarding patient treatment.
- Device Description: The description details a laboratory test process involving reagents and an instrument to analyze a biological sample.
- Performance Studies: The document includes performance studies demonstrating the analytical performance of the assay, which is typical for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (P8900251) is a strong indicator that this device is being submitted for regulatory review as an IVD, often compared to a previously cleared IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 Calibrators are for the calibration of 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.
Product codes (comma separated list FDA assigned to the subject device)
MKW, DLJ
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. 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 centrifuged. 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. Cyclosporine 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical and Hospital laboratories
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)
Precision: A study was performed with the ARCHITECT Cyclosporine assay based on guidance 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 assayed, 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 Cyclosporine 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 cyclosporine 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 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.
| Metabolite | Amount Added (ng/mL) | Mean Excess Concentration Detected (ng/mL, n=5) | % Cross Reactivity |
|---|---|---|---|
| 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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for sensitivity, specificity, total precision %CV, and mean recovery.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P8900251, P8900253
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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 Parkway
Malvern, PA 19355 |
|---------------------------|------------------------------------------------------------------------------|
| Contact person: | Stacey Moll
(610) 240-3843
molls@fdi.com |
| Summary preparation date: | March 10, 2008 |
Name of Device
| Trade/Proprietary Name: | ARCHITECT Cyclosporine Assay
ARCHITECT Cyclosporine Calibrators |
|-------------------------|--------------------------------------------------------------------|
| Common/Usual Name: | Cyclosporine Test Systems
Calibrator |
| Regulation Number: | 21 CFR 862.1235
21 CFR 862.3200 |
| Regulatory Class: | Class II |
| Product Code: | MKW
DLJ |
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
1
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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.
2
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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 of | |||
| Observations | Intercept | ||
| (95% CIa) | Slope | ||
| (95% CI) | Correlation | ||
| Coefficient | |||
| 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 of | |||
| Observations | Intercept | ||
| (95% Cl) | Slope | ||
| (95% CI) | Correlation | ||
| Coefficient | |||
| 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 Cyclosporine | |
| Monoclonal 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 of | |
| cyclosporine in human whole | ||
| blood as an aid in the | ||
| management of heart, liver and | ||
| kidney transplant patients | ||
| receiving cyclosporine therapy. | Quantitative determination of | |
| cyclosporine in human whole | ||
| blood as an aid in the | ||
| management of heart, liver and | ||
| kidney transplant patients | ||
| receiving cyclosporine therapy. | ||
| Type of Specimen | Human Whole Blood | Human Whole Blood |
| Specimen Pretreatment | ||
| Step | Manual extraction of cyclosporine | |
| in human whole blood | Manual extraction of cyclosporine | |
| in 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 methanol | |
| and ethylene glycol. | Zinc sulfate solution in methanol | |
| and ethylene glycol | ||
| Solubilization Reagent | Surfactants in water | Surfactants in water |
| Differences | ||
|---|---|---|
| ARCHITECT Cyclosporine | ||
| (Proposed Device) | TDx/TDxFLx Cyclosporine | |
| Monoclonal Whole Blood | ||
| (Predicate Device) | ||
| P890025⁴ and supplement 7 | ||
| Instrument System | ARCHITECT System | TDx/TDxFLx System |
| Principle of Operation | Chemiluminscent Microparticle | |
| Immunoassay (CMIA) | Fluorescence Polarization | |
| Immunoassay (FPIA) | ||
| Detection | Cyclosporine acridinium-labeled | |
| conjugate in citrate buffer with | ||
| detergent | 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 with
protein stabilizers. | stabilizer. |
|------------------------------------|------------------------------------------------------------|--------------------------------------------------|
| Classification and
Product Code | Class II, MKW | Class II, MGU |
| Specimen Collection
Method | EDTA Whole Blood Collection
Tubes | EDTA and Heparin Whole Blood
Collection 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
5
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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 | Amount
Added
(ng/mL) | Mean Excess
Concentration
Detected
(ng/mL, n=5) | % Cross
Reactivitya |
|------------|----------------------------|----------------------------------------------------------|------------------------|
| 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.
6
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).
7
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
8
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