(36 days)
Not Found
No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
The device is described as an "in-vitro diagnostic medical device" intended for quality control in laboratory testing, not for direct therapeutic use on patients.
No
Explanation: The device is described as "in-vitro diagnostic medical devices intended for use as assayed quality control material," meaning its purpose is to monitor the precision of laboratory tests, not to diagnose a patient directly. It is a control material used in diagnostics, but not a diagnostic device itself.
No
The device description clearly states the controls are prepared from whole human blood and provided in lyophilized form, indicating a physical, biological product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine."
This statement directly identifies the device as an in-vitro diagnostic medical device.
N/A
Intended Use / Indications for Use
The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
Product codes
LAS
Device Description
The Microgenics Cyclosporine Controls are prepared from whole human blood, with pure chemicals stabilizers added. The control kit includes five separate controls known as C1, C2, C3, C4 and C5 with target concentrations of approximately 70, 200, 350, 700 and 1600 ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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7
OCT 17 2003
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
Submitter:
Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5000 Facsimile: (510) 979-5002
Contact Person:
David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212
Preparation Date:
September 10, 2003
Device Information:
| Device Classification Name: | Drug Specific Contr |
|---|---|
| Common/Usual Name: | Cyclosporine Immu |
| Proprietary Name: | Microgenics Cyclos |
| Regulation Number: | 21 CFR§862.3280 |
| Regulatory Name: | Clinical toxicology |
| Product Code: | LAS |
| Regulatory Class: | Class I |
trol Materials unosuppressive Drug Control sporine Controls control material
Predicate Devices:
CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616) Lyphochek Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories.
Device Description:
The Microgenics Cyclosporine Controls are prepared from whole human blood, with pure chemicals stabilizers added. The control kit includes five separate controls known as C1, C2, C3, C4 and C5 with target concentrations of approximately 70, 200, 350, 700 and 1600
1
ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.
Intended Use:
The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
Comparison to Predicate Device(s):
The Microgenics Cyclosporine Controls are substantially equivalent to the CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616) and the Lyphochek® Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories. Moreover, the Microgenics Cyclosporine Controls are manufactured using methods virtually identical to those used for manufacture of the CEDIA® Cyclosporine Plus High Range Controls 4 and 5.
| Device
Characteristics | Subject Device | Predicate Device
(K030616) | Predicated Device
(K022041) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Microgenics Cyclospor-
ine Controls, consisting
of levels 1 through 5, are
in-vitro diagnostic
medical devices intended
for use as assayed quality
control material to
monitor the precision of
laboratory testing
procedures for
cyclosporine. | CEDIA® Cyclosporine
Plus High Range Controls
are intended for use as an
assayed quality control
material to monitor the
precision of laboratory
procedures for
cyclosporine. | Lyphochek® Whole
Blood Control is intended
for use as an assayed
quality control material to
monitor the precision of
laboratory testing
procedures for
cyclosporine. |
| Matrix | Processed Human Whole
Blood | Processed Human Whole
Blood | Processed Human Whole
Blood |
| Form | Lyophilized | Lyophilized | Lyophilized |
| Analytes | Cyclosporine | Cyclosporine | Cyclosporine, Lead, Red
Call Folate, and
Tacrolimus |
| Levels | Five (5) Levels | Two (2) Levels | Three (3) Levels |
| Reconstituted Vial
Claim | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C.
Exception: Red cell folate
is stable for 3 days at 2°C
to 8°C |
| Storage | 2°C to 8°C until
expiration date | 2°C to 8°C until
expiration date | 2°C to 8°C until
expiration date |
| Stability | Until expiration date
noted on vial label | Until expiration date
noted on vial label | Until expiration date
noted on vial label |
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Summary:
The information provided in this pre-market notification demonstrates that the Microgenics Cyclosporine Controls (Assayed and Unassayed) are substantially equivalent to the previously cleared predicate devices. Substantial equivalence was demonstrated through comparison of intended use and physical properties to commercially available devices. The information supplied in this pre-market notification provides reasonable assurance the Microgenics Cyclosporine Controls are safe and effective for the stated intended use.
CEDIA® is a registered trademark of Roche Diagnostics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with wavy lines below them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 17 2003
David Casal, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538
Re: K032842
Trade/Device Name: Microgenics Cyclosporine Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS Dated: September 10, 2003 Received: September 16, 2003
Dear Dr. Casal:
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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Ko32842
510(k) Number (if known):
Microgenics Cyclosporine Controls Device name:
Indications for Use:
The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the Counter Use_
(per 21 CFR §801.109
9
(Optional Format 1-2-96)
Albert Cooper
Division Sign-Off for Tear Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 303 2842