(33 days)
Not Found
K041838/A001
No
The document describes quality control materials for laboratory assays and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
This device is described as a "consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations" and is used to assure "consistent performance of reagent and instrument," not to directly treat a medical condition.
No.
The device is described as a "consistent test sample of known concentration for monitoring assay conditions," which indicates it is used for quality control purposes in laboratory tests, not to diagnose a patient's condition.
No
The provided text describes chemical control samples used in clinical laboratory determinations. These are physical substances, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the products (MAS® chemTRAK® · H, DADE® Moni-Trol® • H, and OLYMPUS Chemistry Control) are "intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations." This describes a product used in vitro (outside the body) to assess the performance of diagnostic tests.
- Function: The products are used to "monitor assay conditions" and "assure consistent performance of reagent and instrument." This is a core function of quality control materials used in IVD testing.
- Setting: The intended user is in a "clinical laboratory," which is the typical setting for IVD testing.
While the document lacks details about the device description, image processing, AI, etc., the intended use alone is sufficient to classify these products as IVDs. They are used in vitro to provide information about the performance of diagnostic assays.
N/A
Intended Use / Indications for Use
The MAS® chemTRAK®. H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges us a means of assuring consistent performance of reagent and instrument.
The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Product codes
JJY
Device Description
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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
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Key Metrics
Not Found
Predicate Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
APR 2 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Penny M. Layman Manager, Regulatory Affairs Medical Analysis Systems, Inc, 5300 Adolfo Road Camarillo, CA 93012
Re: K030942
Trade/Device Name: MAS® chemTRAK® H, DADE® Moni-Trol® H, and OLYMPUS Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: March 24, 2003 Received: March 26, 2003
Dear Ms. Layman:
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 net 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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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 Putman
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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Page _ 1 of _l _
510(k) Number (if known): Ko30942
Device Name:
MAS® chemTRAK® · H Liquid Assayed Chemistry Control
DADE® Moni-Trol® · H Liquid Assayed Chemistry Control
OLYMPUS Chemistry Control Liquid Assayed Chemistry Control
Indications for Use:
The MAS® chemTRAKE.• H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges us a means of assuring consistent performance of reagent and instrument.
The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
coopes
(Division Sign-Off)
Division of Clinical Laboratory Levice.
510(k) Number K030947
510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, IF NEEDED)
| (ODE) | Concurrence of CDRH, Office of Device Evaluation |
|---|---|
| ------- | -------------------------------------------------- |
Prescription Use 1 Use
OR
Over-The-Counter
(Per 21 CFR 801.109) 1-2-96)
(Optional Format