(29 days)
P920031
Not Found
No
The device description details a homogeneous enzyme immunoassay based on recombinant DNA technology and spectrophotometric measurement. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) assay designed to quantitatively measure cyclosporine levels in human whole blood. It is used as an "aid in the management of therapy," meaning it provides information for treatment decisions, rather than directly treating a condition itself.
Yes
The device aids in the management of therapy by quantitatively determining cyclosporine levels in blood, which is a diagnostic function to monitor drug efficacy and toxicity in transplant patients.
No
The device description clearly states it is a "two-reagent set" and describes a chemical assay based on enzyme activity and spectrophotometric measurement, indicating it is a hardware/chemical-based diagnostic assay, 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 cyclosporine in human whole blood." This involves testing a sample taken from the human body (whole blood) outside of the body (in vitro).
- Purpose: The purpose is "as an aid in the management of therapy in kidney, liver, and heart transplants." This indicates it's used for diagnostic or monitoring purposes related to a medical condition or treatment.
- Device Description: The description details a "homogeneous enzyme immunoassay system" that measures a substance in a sample. This is a common type of in vitro diagnostic test.
- Sample Type: The assay uses "human whole blood," which is a biological sample.
- Performance Studies: The document includes performance data like accuracy and imprecision, which are standard for IVD devices to demonstrate their reliability for clinical use.
- Predicate Device: The mention of a "Predicate Device" (P920031; EMIT 2000 Cyclosporine Specific Assay) strongly suggests this device is being compared to a previously cleared IVD, a common process for regulatory submission of new IVDs.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIA Cyclosporine Plus Assay is for the quantitative determination of cyclosporine in human whole blood using automated clinical chemistry analyzers as an aid in the management of therapy in kidney, liver, and heart transplants. The CEDIA Cyclosporine Calibrators are used to calibrate the CEDIA Cyclosporine Plus Assay in human whole blood.
Product codes
MKW; JIS
Device Description
The CEDIA Cyclosporine Plus Assay is a two-reagent set intended to be used with automated clinical chemistry analyzers. The assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß galactosidase, which has been genetically engineered into two inactive fragments, termed Enzyme Acceptor (EA) and Enzyme Donor (ED) spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, to generate a color change that can be measured spectrophotometrically.
In the CEDIA Cyclosporine Plus Assay, drug in the sample competes with drug conjugated to ED for antibody binding sites. If drug is present in the sample, it binds to antibody, leaving the EDdrug conjugate free to reassociate with EA to form active ß-galactosidase. If no drug is present in the sample, antibody binds to the ED-cyclosporine conjugate, inhibiting the reassociation of inactive B-galactosidase fragments, and thus reducing the amount of active enzyme formed. The amount of active enzyme formed, and resulting absorbance change, is proportional to the amount of CEDIA Cyclosporine Plus Assay present in the sample.
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)
Accuracy: Method comparison of all transplant types to an HPLC reference method yielded the following results:
Low range y = 0.99x + 8
r = 0.93, S.E.E. = 25.79;
High range y = 0.97x + 98
r = 0.970, S.E.E. = 80.65;
Assay Range: Low 25 to 450 ng/mL.
High 450 to 2000 ng/mL.
Within Run Imprecision: Percent CVs across 5 levels of cyclosporine concentrations were between 3.0% and 8.0%.
Total Imprecision: Percent CVs across 5 levels of cyclosporine concentrations were between 4.5% and 9.6% or S.D =7.4 for a control at 46 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Low range y = 0.99x + 8
r = 0.93, S.E.E. = 25.79;
High range y = 0.97x + 98
r = 0.970, S.E.E. = 80.65;
Within Run Imprecision: Percent CVs across 5 levels of cyclosporine concentrations were between 3.0% and 8.0%.
Total Imprecision: Percent CVs across 5 levels of cyclosporine concentrations were between 4.5% and 9.6% or S.D =7.4 for a control at 46 ng/mL.
Predicate Device(s)
P920031
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 4 2002
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: K . . . . . . .
Submitter Information (21 CFR 807.92(a)(1))
| Submitter: | Microgenics Corporation |
|---|---|
| 46360 Fremont Boulevard | |
| Fremont, CA 94538 | |
| Phone: 1-510-979-5169 | |
| FAX: 1-510-979-5455 |
- Name Contact: Regulatory Specialist
June 11, 2002 Summary date:
Name of Device and Classification (21 CFR 807.92(a)(2))
CEDIA® Cyclosporine Plus Assay Name (trade):
Name (usual): Cyclosporine Assay
Classification: Unknown
Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3))
CEDIA Cyclosporine Plus Assay is substantially equivalent to EMIT 2000 Cyclosporine Specific Assay (Dade Behring Inc., San Jose, CA), cleared under premarket notification P920031
CEDIA Cyclosporine Plus Assay is identical or similar to its predicate in terms of intended use, method principle, device components, risk to the patient, and clinical performance.
Description of Device (21 CFR 807.92 (a)(4))
The CEDIA Cyclosporine Plus Assay is a two-reagent set intended to be used with automated clinical chemistry analyzers. The assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß galactosidase, which has been genetically engineered into two inactive fragments, termed Enzyme Acceptor (EA) and Enzyme Donor (ED) spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, to generate a color change that can be measured spectrophotometrically.
Microgenics Corporation CEDIA Cyclosporine Plus Assay 510(k) Submission
Page 30 of 33
1
In the CEDIA Cyclosporine Plus Assay, drug in the sample competes with drug conjugated to ED for antibody binding sites. If drug is present in the sample, it binds to antibody, leaving the EDdrug conjugate free to reassociate with EA to form active ß-galactosidase. If no drug is present in the sample, antibody binds to the ED-cyclosporine conjugate, inhibiting the reassociation of inactive B-galactosidase fragments, and thus reducing the amount of active enzyme formed. The amount of active enzyme formed, and resulting absorbance change, is proportional to the amount of CEDIA Cyclosporine Plus Assay present in the sample.
Intended Use (21 CFR 807.92 (a)(5))
The CEDIA Cyclosporine Plus Assay is for the quantitative determination of cyclosporine in human whole blood using automated clinical chemistry analyzers as an aid in the management of therapy in kidney, liver, and heart transplants. The CEDIA Cyclosporine Calibrators are used to calibrate the CEDIA Cyclosporine Plus Assay in human whole blood.
Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))
A summary table of the similarities and difference between CEDIA Cyclosporine Plus Assay and the predicate device follows.
Comparison Table:
CEDIA Cyclosporine Plus Assay vs. EMIT 2000 Cyclosporine Specific Assay
| | EMIT 2000 Cyclosporine Specific Assay
(P920031) | CEDIA Cyclosporine Plus Assay
(new device) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | | |
| Indications
for Use | The Emit 2000 Cyclosporine Specific
Assay is for in vitro diagnostic use on the
Roche Diagnostics Systems COBAS MIRA,
COBAS MIRA S and COBAS MIRA Plus
chemistry systems for the quantitative
analysis of cyclosporine (CsA) in human
whole blood as an aid in the management
of cyclosporine therapy in kidney, heart,
and liver transplants. | The CEDIA Cyclosporine Plus
Assay is for the quantitative
determination of cyclosporine in
human whole blood using
automated clinical chemistry
analyzers as an aid in the
management of therapy in kidney,
liver, and heart transplants. The
CEDIA Cyclosporine Calibrators
are used to calibrate the CEDIA
Cyclosporine Plus Assay in
human whole blood. |
| Method
Principle | The assay uses a mouse monoclonal antibody
with specificity to cyclosporine and a second
mouse monoclonal antibody specific for a
major metabolite of cyclosporine, AM9 (M1)
to prevent metabolite binding to the primary
antibody.
The assay is based on competition for
cyclosporine antibody binding sites between
analyte in the sample and cyclosporine labeled
with G6-PDH. Active (unbound) enzyme
converts NAD to NADH, resulting in an
absorbance change measured | The CEDIA Cyclosporine Plus Assay is
a two-reagent set intended to be used
with automated clinical chemistry
analyzers. The assay uses recombinant
DNA technology (US Patent No.
4708929) to produce a unique
homogeneous enzyme immunoassay
system. The assay is based on the
bacterial enzyme $ β $ -galactosidase,
which has been genetically engineered
into two inactive fragments. These
fragments, termed Enzyme Acceptor
(EA) and Enzyme Donor (ED) |
| Device Name | EMIT 2000 Cyclosporine Specific Assay
(P920031) | CEDIA Cyclosporine Plus Assay
(new device) |
| Method
Principle,
continued | spectrophotometrically.
Before testing, samples are pretreated with
methanol. The pretreatment lyses the cells,
solubilizes the cyclosporine, and precipitates
most of the blood proteins. The samples are
centrifuged, and an aliquot of the resulting
supernatant is then assayed | (EA) and Enzyme Donor (ED),
spontaneously reassociate to form fully
active enzyme, which, in the assay
format, cleaves a substrate to generate a
color change that can be measured
spectrophotometrically.
In the CEDIA Cyclosporine Plus
Assay, cyclosporine in the sample
competes with the cyclosporine
conjugated to ED for antibody binding
sites. If cyclosporine is present in the
sample, it binds to the antibody, leaving
the ED-cyclosporine conjugate free to
reassociate with EA to form active β-
galactosidase. If no cyclosporine is
present in the sample, antibody binds to
the ED-conjugate, inhibiting the
reassociation of inactive β-
galactosidase fragments, and thus
reducing the amount of active enzyme
formed. The amount of active enzyme
formed and the resulting absorbance
change are proportional to the amount
of cyclosporine present in the sample.
The pretreatment reagent lysis the cell |
| Components | - Reagent A
- Enzyme B Reagent | and solubilizes the whole blood for
testing. - Enzyme Acceptor Reagent
- Enzyme Acceptor Buffer
- Enzyme Donor Reagent
- Enzyme Donor Buffer
- Lysing Reagent |
| Risk to patient | An in vitro diagnostic device that can be
used as an aid in the management of
cyclosporine therapy. | An in vitro diagnostic device that can
be used as an aid in the
management of patients receiving
cyclosporine. |
| Clinical
Performance | Accuracy: (See Attachment B: Predicate
Device Labeling, Section 11, Table 10.) The
Syva Emit Package Insert provides Method
Comparison Data from studies at four separate
sites. Below our the results from one repre-
sentative study comparing all 3 transplant
types (heart, lung, kidney) to an HPLC
Reference Method: | Accuracy: Method comparison of all
transplant types to an HPLC reference
method yielded the following results:
Low range y = 0.99x + 8
r = 0.93, S.E.E. = 25.79; |
| Device Name | EMIT 2000 Cyclosporine Specific Assay
(P920031) | CEDIA Cyclosporine Plus Assay
(new device) |
| Clinical
Performance,
continued | Site 4: y=1.05 + 12; r = 0.96, S.E.E. = 25.33
Assay Range: 0 to 500 ng/mL. | High range y = 0.97x + 98
r = 0.970, S.E.E. = 80.65;
Assay Range: Low 25 to 450 ng/mL.
High 450 to 2000 ng/mL. |
| | Within Imprecision: Percent CVs across 3
levels of cyclosporine concentrations were
between 3.0% and 5.0%.
Total Imprecision: Percent CVs across 3 levels
of cyclosporine concentrations were between
4.5% and 10.5%. | Within Run Imprecision: Percent CVs
across 5 levels of cyclosporine
concentrations were between 3.0% and
8.0%.
Total Imprecision: Percent CVs across
5 levels of cyclosporine concentrations
were between 4.5% and 9.6% or S.D
$=7.4$ for a control at 46 ng/mL. |
Microgenics Corporation CEDIA Cyclosporine Plus Assay 510(k) Submission
Page 31 of 33
2
Microgenics Corporation
CEDIA Cyclosporine Plus Assay
510(k) Submission
Page 32 of 33
3
End of 510(k) Summary
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a stacked formation. The profiles are depicted with simple, curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark Hamilton Smith Regulatory Specialist Microgenics Corporation 46360 Fremont Boulevard Fremont, CA 94538
Re: K023208
Trade/Device Name: CEDIA® Cyclosporine Plus Assay Regulation Number: 21 CFR 862.1235 Regulation Name: Cyclosporine test system Regulatory Class: Class II Product Code: MKW; JIS Dated: September 24, 2002 Received: September 25, 2002
Dear Mr. Smith:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
STATEMENT OF INTENDED USE
510(K) Number (if known): not known KOA 3308
Device Name: CEDIA® Cyclosporine Plus Assay
Indications for Use:
The CEDIA Cyclosporine Plus Assay is for the quantitative determination of cyclosporine in human whole blood using automated clinical chemistry analyzers as an aid in the management of therapy in kidney, liver, and heart transplants. The CEDIA Cyclosporine Calibrators are used to calibrate the CEDIA Cyclosporine Plus Assay in human whole blood.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023208
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-the-Counter Use ______
Concurrence of CDRH, Office of Device Evaluation (ODE)
Microgenics Corporation
CEDIA Cyclosporine Plus Assay
510(k) Submission
Page 14 of 33