(56 days)
Not Found
Not Found
No
The document describes a control serum for monitoring clinical chemistry tests, with no mention of AI or ML.
No.
Explanation: The device is an in vitro diagnostic control serum intended for monitoring the accuracy and precision of clinical chemistry test procedures, not for treating any medical condition.
No
The provided text states that the device is "intended for monitoring the accuracy and precision of clinical chemistry test procedures." This indicates it is a quality control material rather than a device used to diagnose a patient's condition. While it is for "in vitro diagnostic use," this phrase can refer to products used in the overall diagnostic process, not just those making direct diagnoses.
No
The device described is a control serum, which is a physical substance used for quality control in clinical chemistry tests. It is not a software application.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The key phrase that confirms this is:
- "It is for in vitro diagnostic use only."
This statement explicitly indicates that the product is intended for use in diagnostic procedures performed outside of the living body. The intended use of monitoring the accuracy and precision of clinical chemistry test procedures further supports its classification as an IVD, as these tests are typically performed on biological samples in a laboratory setting for diagnostic purposes.
N/A
Intended Use / Indications for Use
Data-Trol A Abnormal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Data-Trol N Normal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Product codes
JJY
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)
Not Found
Reference Device(s)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Re:
Public Health Service
SEP 2 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Melita Lambiris Quality Assurance Manger Thermo Electron Corporation 189-199 Browns Road Noble Park, Victoria 3174 Australia
K052056 Trade/Device Name: Data-Trol A Abnormal Control Serum Data-Trol N Normal Control Serum Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 8, 2005 Received: September 12, 2005
Dear Ms. Lambiris:
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).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegn marketing of substantial equivalence of your device to a legally promatics nonifeation: "The PDF 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, If you desire specific information and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the Villo Diagnostic Device Drana.com and sees to premarket notification" (21CFR Part 807.97). It guilation chitica, "Whisording of roien on your responsibilities under the Act from the You may offail bunci general mormational 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/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K052056 |
|---|---|
| Device Name: | Data-Trol A Abnormal Control Serum |
| Data-Trol N Normal Control Serum | |
| Indications For Use: | Data-Trol A Abnormal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only. |
Data-Trol N Normal Control serum is intended for monitoring the accuracy and precision of clinical chemistry test procedures. It is for in vitro diagnostic use only.
Prescription Use X (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
Office of In Vitre Diagnostic Device Evaluation and Safety
510(k) K052056