(41 days)
Not Found
Not Found
No
The document describes a human serum-based control for immunoassay procedures and makes no mention of AI or ML technology.
No
The device is described as an "unassayed control" used to monitor analytical procedures and reagents for detecting infectious disease agents. It is an in vitro diagnostic control and not used directly for treating a patient.
No
This device is described as an "unassayed control" used to "monitor analytical procedures and reagents." It explicitly states, "These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors." This indicates it's for quality control of diagnostic tests, not for directly diagnosing a patient.
No
The device description explicitly states it is a "human serum based unassayed control," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is used to "monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens" using "in vitro immunoassay procedures." This clearly indicates it's used outside of the body to analyze biological samples.
- Device Description: The device is described as a "human serum based unassayed control," which is a common type of material used in IVD testing to ensure the accuracy and reliability of the test.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help diagnose diseases or conditions. The SYSCON IDC-G fits this definition perfectly.
N/A
Intended Use / Indications for Use
SYSCON IDC-G is a human serum based unassayed control used to monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens. These controls are to be used with in vitro immunoassay procedures for the qualitative determination of Chlamydia, Epstein-Barr related antigen, Borrelia burgdorferi, Herpes Complex, Hepatitis, and TORCH. These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors.
Product codes
MJX, MJY
Device Description
Not Found
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): 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.
Not Found
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
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 4 1997
Richard Lenart Regulatory Affairs Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071-2862
Re: K974262 Trade Name: Syscos IDC - G, IDC, BSC, IDC - G Regulatory Class: I Product Code: MJX, MJY Dated: November 11, 1997 Received: November 13, 1997
Dear Mr. Lenart:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.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
2
510 (k) NUMBER (IF KNOWN): K974262
DEVICE NAME: SYSCON IDC-G, NEGATIVE AND POSITIVE
INDICATIONS FOR USE:
SYSCON IDC-G is a human serum based unassayed control used to monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens. These controls are to be used with in vitro immunoassay procedures for the qualitative determination of Chlamydia, Epstein-Barr related antigen, Borrelia burgdorferi, Herpes Complex, Hepatitis, and TORCH. These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrent of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Sally ? Selezaker | |
| Prescription Use | ✓ |
| (Per 21 CFR 801.109 | |
| OR acting for Over-The-Counter-Use _____ | |
| John Tichiniut (Optional Format 1-2-96) | |
| at Laboratory Devices |