(128 days)
P97000
Not Found
No
The summary describes a standard immunoassay technology (CMIA) for quantitative determination of a drug. There is no mention of AI, ML, or any computational methods beyond basic data analysis (regression, statistics) for performance evaluation.
No
The device is an in vitro diagnostic (IVD) assay designed to quantify tacrolimus levels in human whole blood. It aids in the management of patients receiving tacrolimus therapy but does not directly administer therapy or provide treatment.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states that the device is for the "quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System" and "is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy." This indicates it provides information to diagnose or manage a patient's condition.
No
The device is a chemiluminescent Microparticle immunoassay (CMIA) which involves physical reagents, manual sample preparation, and analysis on the ARCHITECT i System hardware, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of tacrolimus in human whole blood" and is used "as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy." This involves testing a sample taken from the human body to provide information for medical purposes.
- Device Description: The description details a "chemiluminescent Microparticle immunoassay (CMIA)" performed on "human whole blood." This is a laboratory test conducted on a biological sample.
- Components: The description mentions "ARCHITECT Tacrolimus Calibrators" and "ARCHITECT Tacrolimus Whole Blood Precipitation Reagent," which are components used in the in vitro testing process.
- Performance Studies: The document includes performance studies conducted using "human whole blood specimens" to evaluate the assay's performance against other methods (IMx Tacrolimus II and LC/MS/MS). This is typical for IVD devices.
- Intended User/Care Setting: The intended users are "Clinical and Hospital laboratories," which are settings where in vitro diagnostic testing is performed.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Reagent Kit
The ARCHITECT Tacrolimus assay is a chemiluminescent Microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Tacrolimus assay is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
Calibrator Kit
The ARCHITECT Tacrolimus Calibrators are for the ARCHITECT i System when used for the quantitative determination of tacrolimus in human whole blood.
Whole Blood Precipitation Reagent
The ARCHITECT Tacrolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (human whole blood patient specimens, controls, and ARCHITECT Tacrolimus Calibrators) to be tested on the ARCHITECT i System.
Product codes
MLM, JIT
Device Description
The ARCHITECT Tacrolimus assay is a delayed one-step immunoassay for the quantitative determination of tacrolimus 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 extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System.
Sample, assay diluent, and anti-tacrolimus coated paramagnetic microparticles are combined to create a reaction mixture. Tacrolimus present in the sample binds to the anti-tacrolimus coated microparticles. After a delay, tacrolimus acridinium-labeled conjugate is added to the reaction mixture. The tacrolimus on the acridinium-labeled conjugate competes for the available binding sites on the microparticles. Following an incubation, the microparticles are washed, and pretrigger 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 tacrolimus in 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
Not Found
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
Precision: A study was performed with the ARCHITECT Tacrolimus assay based on guidance from the Clinical and Laboratory Standards Institute, document (CLSI, formerly NCCLS) Protocol EP5-A2. Abbott Immunosuppressent-MCC (levels 1, 2, and 3) and five whole blood panels 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.
Linearity: A dilution linearity study was performed by diluting high concentration tacrolimus whole blood specimens with the ARCHITECT Tacrolimus Calibrator A. The concentration of Tacrolimus was determined for each dilution of sample and the mean percent (%) recovery was calculated.
Functional Sensitivity: Whole blood specimens were spiked with tacrolimus to achieve approximate concentrations from 0.2 to 4.4 ng/mL and tested in replicates of 10, twice a day, for five days.
Analytical Sensitivity: The limit of detection for the ARCHITECT Tacrolimus assay, defined as the concentration at two standard deviations above the ARCHITECT Tacrolimus Calibrator A (0.0 ng/mL) was calculated to be 0.3 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]).
Specificity: Aliquots of whole blood specimens were augmented with tacrolimus, targeting values ranging Alliquette of these five specimens were spiked with cross-reactant solution.
Key Metrics
Precision: The total precision %CV of the ARCHITECT Tacrolimus assay was determined to be less than or equal to 10%.
Linearity: The ARCHITECT Tacrolimus assay was determined to have a mean recovery within 10% of the expected result for diluted samples.
Functional Sensitivity: At the upper 95% confidence limit, the lowest ARCHITECT Tacrolimus assay value exhibiting a 20% CV was calculated to be 0.8 ng/mL.
Analytical Sensitivity: The limit of detection for the ARCHITECT Tacrolimus assay, defined as the concentration at two standard deviations above the ARCHITECT Tacrolimus Calibrator A (0.0 ng/mL) was calculated to be 0.3 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: The average recovery observed during the study ranged from 95 to 105%.
Specificity:
M-I (13-O-demethyl-tacrolimus): Amount Added 10 ng/mL, Mean Excess Concentration Detected
§ 862.1678 Tacrolimus test system.
(a)
Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus 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 tacrolimus.(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
Image /page/0/Picture/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc". The logo consists of a stylized three-leaf clover design on the left, followed by the company name in bold, sans-serif font. Above the logo, there is a handwritten code "K070820".
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:
Submitter Information
AUG - 1 2007
- Fujirebio Diagnostics, Inc. Address: 201 Great Valley Parkway Malvern, PA 19355
- Diana L. Dickson Contact person: (610) 240-3917 dicksond@fdi.com
Summary preparation date: March 23, 2007
Name of Device
-
Trade/Proprietary Name: ARCHITECT Tacrolimus Assay ARCHITECT Tacrolimus Calibrators
MLM DLJ -
Common/Usual Name: Tacrolimus Test Systems Calibrator
-
Regulation Number: 21 CFR 862.1678 21 CFR 862.3200
Requlatory Class: Class II
Product Code:
Predicate Device
ABBOTT IMx® Tacrolimus II Microparticle Enzyme Immunoassay (P97000)'
Device Description
The ARCHITECT Tacrolimus assay is a delayed one-step immunoassay for the quantitative determination of tacrolimus in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex.
1 note: tacrolimus test systems have been reclassified into Class II since the predicate was approved
1
Image /page/1/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized symbol on the left and the company name on the right. The symbol is composed of three curved shapes, one solid black, one white, and one with vertical lines. The company name is written in a bold, sans-serif font, with "FUJIREBIO" on the top line and "Diagnostics, Inc" on the bottom line.
Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System.
Sample, assay diluent, and anti-tacrolimus coated paramagnetic microparticles are combined to create a reaction mixture. Tacrolimus present in the sample binds to the anti-tacrolimus coated microparticles. After a delay, tacrolimus acridinium-labeled conjugate is added to the reaction mixture. The tacrolimus on the acridinium-labeled conjugate competes for the available binding sites on the microparticles. Following an incubation, the microparticles are washed, and pretrigger 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 tacrolimus in the RLUs detected by the ARCHITECT i System optics.
Intended Use
Reagent Kit
The ARCHITECT Tacrolimus assay is a chemiluminescent Microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Tacrolimus assay is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
Calibrator Kit
The ARCHITECT Tacrolimus Calibrators are for the ARCHITECT i System when used for the quantitative determination of tacrolimus in human whole blood.
Whole Blood Precipitation Reagent
The ARCHITECT Tacrolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (human whole blood patient specimens, controls, and ARCHITECT Tacrolimus Calibrators) to be tested on the ARCHITECT i System.
2
Image /page/2/Picture/1 description: The image contains the logo for "FUJIREBIO Diagnostics, Inc." The logo consists of a stylized graphic to the left of the text. The graphic is a combination of black and white shapes with vertical lines. The text is in a bold, sans-serif font, with "FUJIREBIO" on the top line and "Diagnostics, Inc" on the second line.
Statement of Substantial Equivalence
The ARCHITECT Tacrolimus assay is a chemiluminescent Microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Tacrolimus assay is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
The ARCHITECT Tacrolimus assay is substantially equivalent to the IMx Tacrolimus II assay. Both of the devices are IVD products and are indicated for the quantitative determination of tacrolimus in human whole blood and used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.
A study was performed using human whole blood specimens from renal and liver transplant patients receiving tacrolimus therapy, where regression analysis was performed using the Passing-Bablok2 method. Data from the study are summarized in the following table.
| ARCHITECT Tacrolimus vs. IMx Tacrolimus II | |||
|---|---|---|---|
| Number of | |||
| Observations | Intercept | ||
| (95% CIa) | Slope | ||
| (95% CI) | Correlation | ||
| Coefficient | |||
| 124 | 0.37 | ||
| (0.00 to 0.68) | 0.81 | ||
| (0.75 to 0.88) | 0.90 |
a Confidence Interval Specimen Range (ARCHITECT): 2.2 ng/mL to 14.8 ng/mL Specimen Range (IMx): 2.1 nq/mL to 15.9 ng/mL
Additional testing of the above sample was completed with LC/MS/MS, where regression analysis was performed using the Passing-Bablok1 method. Data from the study are summarized in the following table.
| ARCHITECT Tacrolimus vs. LC/MS/MS | ||||
|---|---|---|---|---|
| Number of | ||||
| Observations | Intercept | |||
| (95% Cl) | Slope | |||
| (95% CI) | Correlation | |||
| Coefficient | ||||
| 125 | 0.22 | |||
| (0.02 to 0.48) | 1.07 | |||
| (1.01 to 1.12) | 0.92 |
Specimen Range (ARCHITECT): 2.1 ng/mL to 14.8 ng/mL Specimen Range (LC/MS/MS): 1.78 ng/mL to 19.20 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.
3
Image /page/3/Picture/1 description: The image contains the logo for Fujirebio Diagnostics, Inc. The logo features a stylized graphic to the left of the company name. The graphic is a combination of black and white shapes with vertical lines. The text "FUJIREBIO" is in bold, black letters, and "Diagnostics, Inc" is in a smaller font size below the company name.
A comparison of the features of the ARCHITECT Tacrolimus assay and the IMx Tacrolimus II assay are as follows:
| Similarities | ||
|---|---|---|
| ARCHITECT Tacrolimus | ||
| (Proposed Device) | IMx Tacrolimus II | |
| (Predicate Device) | ||
| P9700071 | ||
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification and | ||
| Product Code | Class II, MLM | Class II, MLM |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | Quantitative determination of | |
| tacrolimus in human whole blood | ||
| as an aid in the management of | ||
| liver and kidney allograft patients | ||
| receiving tacrolimus therapy. | Quantitative determination of | |
| tacrolimus in human whole blood | ||
| as an aid in the management of | ||
| liver and kidney allograft patients | ||
| receiving tacrolimus therapy. | ||
| Type of Specimen | Human Whole Blood | Human Whole Blood |
| Specimen Collection | ||
| Method | EDTA Whole Blood Collection | |
| Tubes | EDTA Whole Blood Collection | |
| Tubes | ||
| Specimen Pretreatment | ||
| Step | Manual extraction of tacrolimus in | |
| human whole blood | Manual extraction of tacrolimus in | |
| human whole blood | ||
| Calibrators | 6 Levels (0 - 30 ng/mL) | 6 Levels (0 - 30 ng/mL) |
| Calibrator Matrix | Processed human whole blood | Processed human whole blood |
| Antibody | Mouse monoclonal (anti - | |
| tacrolimus) | Mouse monoclonal (anti - | |
| tacrolimus) | ||
| Interpretation of Results | Calibrator Curve | |
| An indirect relationship exists | ||
| between the amount of tacrolimus | ||
| in the sample and the light | ||
| detected by the instrument system | Calibrator Curve | |
| An indirect relationship exists | ||
| between the amount of tacrolimus | ||
| in the sample and the light | ||
| detected by the instrument system |
| Differences | ||
|---|---|---|
| ARCHITECT Tacrolimus | ||
| (Proposed Device) | IMx Tacrolimus II | |
| (Predicate Device) | ||
| P9700071 | ||
| Instrument System | ARCHITECT System | IMx System |
| Principle of Operation | Chemiluminscent Microparticle | |
| Immunoassay (CMIA) | Microparticle Enzyme | |
| Immunoassay (MEIA) | ||
| Conjugate | Tacrolimus-Acridinium Conjugate | |
| in citrate buffer with protein | ||
| stabilizers | Tacrolimus-alkaline phosphatase | |
| in TRIS buffer with protein | ||
| stabilizers | ||
| Microparticles | Anti-tacrolimus (mouse, | |
| monoclonal) coated paramagnetic | ||
| microparticles in EDTA buffer | Anti-tacrolimus (mouse | |
| monoclonal) coated polystyrene | ||
| latex microparticles in TRIS buffer | ||
| Precipitation Reagent | Zinc sulfate solution in methanol | |
| and ethylene glycol. | Zinc sulfate solution in methanol | |
| and Ethylene glycol |
1 note: tacrolimus test systems have been reclassified into Class II since the predicate was approved
4
Image /page/4/Picture/1 description: The image shows the logo for Fujirebio Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a three-part design with a combination of solid black and striped sections. To the right of the graphic, the text "FUJIREBIO" is displayed in bold, uppercase letters, with "Diagnostics, Inc" written in a smaller font size below it.
Performance Characteristics
Precision:
A study was performed with the ARCHITECT Tacrolimus assay based on guidance from the Clinical and Laboratory Standards Institute, document (CLSI, formerly NCCLS) Protocol EP5-A2. Abbott Immunosuppressent-MCC (levels 1, 2, and 3) and five whole blood panels 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 Tacrolimus assay was determined to be less than or equal to 10%.
Linearity:
A dilution linearity study was performed by diluting high concentration tacrolimus whole blood specimens with the ARCHITECT Tacrolimus Calibrator A. The concentration of Tacrolimus was determined for each dilution of sample and the mean percent (%) recovery was calculated.
The ARCHITECT Tacrolimus 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 tacrolimus to achieve approximate concentrations from 0.2 to 4.4 ng/mL and tested in replicates of 10, twice a day, for five days. At the upper 95% confidence limit, the lowest ARCHITECT Tacrolimus assay value exhibiting a 20% CV was calculated to be 0.8 ng/mL.
Analytical Sensitivity:
The limit of detection for the ARCHITECT Tacrolimus assay, defined as the concentration at two standard deviations above the ARCHITECT Tacrolimus Calibrator A (0.0 ng/mL) was calculated to be 0.3 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 95 to 105%.
5
Image /page/5/Picture/1 description: The image shows the logo for FUJIREBIO Diagnostics, Inc. The logo consists of a stylized graphic on the left and the company name on the right. The graphic is a three-part design with a white teardrop shape in the center, flanked by a black shape on the left and a striped shape on the right. The company name is written in bold, black letters, with "FUJIREBIO" on the top line and "Diagnostics, Inc" on the bottom line.
Specificity:
Aliquots of whole blood specimens were augmented with tacrolimus, targeting values ranging Alliquette of 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 |
|--------------------------------------|----------------------------|----------------------------------------------------------|------------------------|
| M-I (13-O-demethyl-
tacrolimus) | 10 |