(31 days)
Not Found
No
The document describes a laboratory control material and its intended use for monitoring the precision of clinical laboratory analysis. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an assayed control material to monitor the ongoing precision of clinical laboratory analysis, not for treating or diagnosing patients.
No
Explanation: This device is a control material used to monitor the precision of laboratory analysis. It does not diagnose medical conditions in patients.
No
The device description clearly states it is a "human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin," indicating it is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the ongoing precision of clinical laboratory analysis" for specific analytes (Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol). This is a classic function of an IVD control material used in a clinical laboratory setting.
- Device Description: The description mentions it's a "human serum based liquid control" containing stabilized analytes. This type of material is designed to be used in vitro (outside the body) to assess the performance of diagnostic tests.
- Intended User / Care Setting: The intended user is "clinical laboratory analysis," which is where IVDs are used.
The fact that it's a control material used to monitor the performance of diagnostic tests for specific analytes in a clinical laboratory setting clearly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 2 2 2008
Image /page/0/Picture/1 description: The image shows the logo for Maine Standards Company. The logo is black and white and features the word "maine" on top of the word "standards". A diagonal line separates the two words. The words "COMPANY INC" are written in small letters below the word "standards".
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: __ Ko82067_"
Submitter: Maine Standards Company Address: 765 Roosevelt Trail Windham, ME 04062 Telephone: 207-892-1300 Fax: 207-892-2266 Holly A. Cressman, Mgr. QA/RA Contact:
Summary prepared on: July 10, 2008
Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Device classification name: Quality control material (assayed and unassayed) Device description: Proprietary Name: MSC Lipid Control Regulation Number: 21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I
Predicate Device:
Bio-Rad Liquichek™ Lipids Control Level 1 (K012513).
Device description: The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol of human origin.
Intended use: The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.
Summary:
The information provided in this pre-market notification demonstrates that the performance of MSC Lipid Control is substantially equivalent in form and function to the predicate devices for its stated intended use.
1
Image /page/1/Picture/1 description: The image shows a logo with a circular border containing text, and a central graphic. The text around the border is in a circular arrangement. The central graphic features a stylized depiction of three curved shapes, resembling birds in flight or abstract waves. The logo appears to be a symbol for an organization or agency, possibly related to health or public service.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Maine Standards Co. c/o Ms. Holly Cressman 765 Roosevelt Trail Windham, ME 04062-5365
AUG 2 2 2008
Re: K082067 Trade Name: MSC Lipid Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Codes: JJY Dated: July 17, 2008 Received: July 22, 2008
Dear Ms. Cressman:
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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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K082067 510(k) Number:
Device Name: MSC Lipid Control
Indications For Use:
The MSC Lipid Control is intended for use as an assayed control material to monitor the ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL Cholesterol, and LDL Cholesterol. This material is intended for use on automated, semi-automated, and manual clinical chemistry analyzer systems.
Prescription Use (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)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K082067
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