(85 days)
No
The document describes a calibration verification test set for clinical chemistry analyzers, which is a standard laboratory quality control material. There is no mention of AI or ML in the intended use, device description, or any other section. The device's function is to provide known concentrations of analytes for verifying the performance of laboratory instruments, not to perform analysis or interpretation using AI/ML.
No.
The device is described as an in vitro diagnostic test set used for verifying calibration and linearity of laboratory instruments for analysis of lipoprotein analytes, not for direct therapeutic intervention or treatment.
No
This device is described as a "Quality control material" intended for "in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity" of clinical chemistry systems. It is used by laboratory professionals to verify the performance of other diagnostic tests and equipment, rather than directly diagnosing disease in a patient.
No
The device description clearly states it is a "human protein serum based calibration verification test set containing multiple levels" and comes in "bottles," indicating it is a physical, in vitro diagnostic material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "intended for in vitro diagnostic use".
- Purpose: The device is used to verify calibration, validate reportable ranges, and determine linearity for specific analytes (cholesterol, HDL-cholesterol, LDL-cholesterol, Apolipoprotein A, and Apolipoprotein B) on clinical chemistry systems. These are all activities performed in a laboratory setting to ensure the accuracy of diagnostic tests.
- User: It is intended for use by "trained laboratory professionals".
- Device Description: It is described as "Quality control material (assayed and unassayed)" and a "calibration verification test set," which are common types of IVD devices used for quality control and calibration in laboratory testing.
The information provided clearly aligns with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VALIDATE Lipoprotein Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).
The VALIDATE Lipoprotein Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in manual, semi-automated and automated clinical chemistry systems for the following analytes: cholesterol, HDL cholesterol, LDL cholesterol, Apolipoprotein A, and Apolipoprotein B.
Product codes
JJY
Device Description
Quality control material (assayed and unassayed)
VALIDATE Lipoprotein Calibration Test Set is a human protein serum based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters. There exists a linear relationship among each set of solutions.
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
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Intended User / Care Setting
trained laboratory professionals
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
The information provided in this pre-market notification demonstrates that the performance i he information provided in this pre-market is substantially equivalent in form of VALIDATE Lipoprolem Calibration Verification Test Set (K012120) for its stated intended use.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for Maine Standards Company. The logo consists of the word "maine" above a horizontal line, with the word "standards" below the line. A diagonal line slashes through the middle of the logo, and the word "COMPANY" is written in smaller letters below "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: K041975."
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt Trail |
| Windham, ME 04062 | |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Christine Beach, Dir. RA/QA |
Summary prepared on: July 14, 2004
Device classification name: Multi-Analyte Controls, All Kinds (Assayed and Unassayed) Device description: Quality control material (assayed and unassayed) Proprietary Name: VALIDATE Lipoprotein Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I
Predicate Device:
-
- Chem 4 Calibration Verification Test Set (K012120), manufactured by Maine Standards Company, Windham, ME.
Device description: VALIDATE Lipoprotein Calibration Test Set is a human protein serum based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters. There exists a linear relationship among each set of solutions.
- Chem 4 Calibration Verification Test Set (K012120), manufactured by Maine Standards Company, Windham, ME.
Intended use: VALIDATE Lipoprotein Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity on clinical chemistry for the following analytes: cholesterol, HDL-cholesterol, LDLcholesterol, Apolipoprotein A (Apo-A), and Apolipoprotein B (Apo-B).
1
Comparison of VALIDATE Lipoprotein Calibration Verification Test Set to the l
eather of the consideration Verification Test Set Companson on Calibration Verification Test Set:
The VALIDATE Lipoprotein Calibration Test Set is substantially equivalent to The VALIDATE Lipoprotein Calibration Test Set (K012120) also manufactured by
the VALIDATE Chem 4 Calibration Verification Test Set (K012120), for its sted use the VALIDATE Chem 4 Gallbration Vermoution 1000 The FDA, for its stated use.
| | VALIDATE Lipoprotein Calibration
Verification Test Set | VALIDATE Chem 4 Calibration
Verification Test Set |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | For in vitro diagnostic use in
quantitatively verifying calibration,
validating reportable ranges, and
determining linearity in automated,
semi-automated and manual chemistry
systems. | For in vitro diagnostic use in quantitatively
verifying calibration, validating reportable
ranges, and determining linearity in
automated, semi-automated and manual
chemistry systems. |
| Analytes | CHOL, HDL, LDL, Apo-A, Apo-B | ALP, ALT, AMY, AST, CK, GGT, LD,
LIP, TBIL, DBIL |
| Matrix | human serum | protein |
| Number of
Levels | 6 including zero | 6 including zero |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Packaging | 5.0 mL each level | 5.0 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | -10 to -20°C | -10 to -20°C |
Summary:
The information provided in this pre-market notification demonstrates that the performance i he information provided in this pre-market is substantially equivalent in form of VALIDATE Lipoprolem Calibration Verification Test Set (K012120) for its stated intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 15 2004
Ms. Christine Beach Director QA/RA Maine Standards Co. 765 Roosevelt Trail Windham. ME 04062
Re: K041975
Trade/Device Name: VALIDATE® Lipoprotein Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 22, 2004 Received: July 22, 2004
Dear Ms. Beach:
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 promated no dicate 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,
Seain M. Cooper, US, DVM.
Jean M. Cooper, MS, 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
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INDICATIONS FOR USE STATEMENT
510(k) Number: K041975
Device Name: VALIDATE® Lipoprotein Calibration Verification Test Set
Indications for Use:
The VALIDATE Lipoprotein Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in manual, semi-automated and automated clinical chemistry systems for the following analytes: cholesterol, HDL cholesterol, LDL cholesterol, Apolipoprotein A, and Apolipoprotein B.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041975