(88 days)
No
The document describes a calibration verification test set for clinical chemistry systems. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis relies on standard linear regression, not AI/ML algorithms.
No.
This device is an in vitro diagnostic test set used to verify the calibration and linearity of chemistry systems for various analytes, not to directly treat or diagnose a patient.
No
This device is for "in vitro diagnostic use" to verify calibration, linearity, and reportable ranges of chemistry systems, not to diagnose a patient's condition. It's used to ensure the accuracy of other diagnostic devices.
No
The device description clearly states it is a "Test Set" containing "purified enzymes in a solution of bovine albumin" in "bottles." This describes a physical, in vitro diagnostic reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "intended for in vitro diagnostic use." It also describes its use in verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems, which are all activities performed in a clinical laboratory setting to ensure the accuracy of diagnostic tests.
- Device Description: The description mentions purified enzymes in a solution, which are reagents used in laboratory testing.
- Intended User/Care Setting: The intended users are "trained laboratory professionals" and the device is used with "automated, semi-automated and manual clinical chemistry systems," all indicative of a clinical laboratory environment.
The purpose of this device is to assess the performance of other diagnostic devices (the chemistry systems) that are used to test patient samples. This fits the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
VALIDATE Chem 10 Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.
The VALIDATE Chem 10 Calibration Verification Test Set is used by trained laboratory professionals for the determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual clinical chemistry systems for the following analytes: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, creatine kinase, lactate dehydrogenase, alkaline phophatase, arnylase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.
Product codes
JJY
Device Description
VALIDATE Chem 10 Calibration Verification Test Set contains purified enzymes in a solution of bovine albumin. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains five (5) levels. Each bottle contains 5.0 milliliters.
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
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
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Summary of Performance Studies
Linear regression analysis was carried out on recovered values for each analyte and Elliour rogression and Jels was cation Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to Tanonally - Squrrater.ce II Test Set and Ortho-Clinical Diagnostics Calibrator Kit 4.
Key Metrics
Not Found
Predicate Device(s)
K910440, Ortho-Clinical Diagnostics VITROS Calibrator Kit 4
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/0 description: The image shows the logo for Maine Standards Company LLC. The word "Maine" is written in a light color above a horizontal line. A thick black diagonal line crosses through the logo, intersecting the word "standards" written in bold black letters. Below "standards" is the text "COMPANY LLC" in smaller, spaced-out letters.
AN U 6 2003
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:
Maine Standards Company Submitter: 765 Roosevelt Trail Address: Windham, ME 04062 207-892-1300 Telephone: Fax: 207-892-2266 Contact: Christine Beach, Mgr. RA/QA
Summary prepared on: October 7, 2002
| Proprietary Name: | VALIDATE Chem 10 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Device:
- DOCUMENT Reflectance II Test Set, K910440, manufactured by 1. CASCO NERL Diagnostics.
- Ortho-Clinical Diagnostics VITROS Calibrator Kit 4 2.
Device description: VALIDATE Chem 10 Calibration Verification Test Set contains purified enzymes in a solution of bovine albumin. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains five (5) levels. Each bottle contains 5.0 milliliters.
Intended use: VALIDATE Chem 10 Calibration Verification Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.
1
Comparison to Predicate Devices:
| | VALIDATE CHEM 10
Calibration Verification
Test Set | DOCUMENT
Reflectance II
Test Set | Ortho-Clinical
Diagnostics VITROS
Calibrator Kit 4 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 110 | R-102 | 1204668 |
| 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 the
quantitative
determination of
linearity in manual,
automated and semi-
automated chemistry
systems. | For use in the
calibration of VITROS
chemistry systems for
the quantitative
measurement
of total and direct
bilirubin. |
| Analytes | ALT, AST, CK, LD, ALP,
AMY, LIP, GGT, TBIL,
Bu/Bc | ALT, AST, CK, LD,
ALP, AMY, GGT | TBIL, Bu/Bc |
| Matrix | Bovine Serum Albumin | Human Serum | Bovine Serum Albumin |
| Number of
Levels | 5 | 5 | 3 (TBIL)
4 (Bu/Bc) |
| Preparation | Liquid,
ready to use | Liquid,
ready to use | Lyophilizied |
| Packaging | 5.0 mL each level | 2 x 2.0 mL each level | 3 mL each level |
| Stability | 9 months | 9 months | 24 hours after
reconstitution |
| Storage | -10 to -20° C. | -10 to -20° C. | -10 to -20° C. |
The performance of VALIDATE Chem 10 Calibration Verification Test Set solutions on the Ortho-Clinical Diagnostics VITROS instrument system as compared to DOCUMENT Reflectance II Test Set and Ortho-Clinical Diagnostics Calibrator Kit 4 has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 10 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 10 Calibration Verification Test Set and the predicate devices are presented in Table 2.
2
| Table 2. | Linear Regression Statistical Comparison between VALIDATE Chem |
|---|---|
| 10 Calibration Verification Test Set and the predicate devices. |
| | VALIDATE
Chem 10
Calibration Verification Test Set | | DOCUMENT
Reflectance II Test Set | |
|---------|----------------------------------------------------------|-------------------------------------------------|-------------------------------------|-------------------------------------------------|
| Analyte | Correlation
Coefficient
(r) | Regression Equation
Y = slope(X) + intercept | Correlation
Coefficient
(r) | Regression Equation
Y = slope(X) + intercept |
| ALP | 0.9973 | 0.8898x + 42.375 | 0.994 | 0.978x - 35.071 |
| ALT | 0.9995 | 0.9722x - 0.0781 | 0.999 | 1.029x - 9.414 |
| AMY | 0.9983 | 0.9189x + 26.206 | 0.999 | 1.002x - 16.822 |
| AST | 0.9990 | 1.0521x - 11.729 | 0.998 | 0.982x - 4.709 |
| CK | 0.9932 | 0.814x + 59.839 | 0.999 | 0.974x + 8.122 |
| GGT | 0.9975 | 1.0994x - 17.786 | 0.999 | 0.987x + 4.625 |
| LD | 0.9997 | 1.0462x - 26.754 | 0.998 | 0.914x + 65.613 |
| LIP | 0.9999 | 0.9779x + 10.265 | 0.998 | 1.019x - 51.514 |
| VALIDATE
Chem 10
Calibration Verification Test Set | | Ortho-Clinical Diagnostics VITROS
Calibrator Kit 4 | | |
|----------------------------------------------------------|-----------------------------------|-------------------------------------------------------|-----------------------------------|-------------------------------------------------|
| Analyte | Correlation
Coefficient
(r) | Regression Equation
Y = slope(X) + intercept | Correlation
Coefficient
(r) | Regression Equation
Y = slope(X) + intercept |
| TBIL | 0.9999 | 0.9887x + 0.0423 | 0.9999 | 0.9537x + 0.1719 |
| Bu | 0.999 | 0.9463x + 0.0471 | 0.9999 | 0.9765x + 0.0402 |
| Bc | 0.9995 | 0.9662x + 0.1465 | 0.9996 | 0.9899x - 0.0115 |
Summary:
Linear regression analysis was carried out on recovered values for each analyte and Elliour rogression and Jels was cation Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to Tanonally - Squrrater.ce II Test Set and Ortho-Clinical Diagnostics Calibrator Kit 4.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a simple, modern design. The text "DEPARTMENT OF HEALTH" is arranged in a circular pattern around the left side of the logo.
Rockville MD 20850
JAN 0 6 2003
Ms. Christine Beach Manager, OA/RA Maine Standards Company 765 Roosevelt Trail - Suite 9A Windham, ME 04062
Re: K023410
Trade/Device Name: Validate Chem 10 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: October 8, 2002 Received: October 10, 2002
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).
4
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 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). Other general information on your responsibilities under the Act may be obtained 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
5
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: Validate Chem 10 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 10 Calibration Verification Test Set is used by trained laboratory professionals for the determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual clinical chemistry systems for the following analytes: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, creatine kinase, lactate dehydrogenase, alkaline phophatase, arnylase, lipase, and total bilirubin. The materials may also be utilized on Ortho-Clinical Diagnostic's Vitros analyzers for determining linearity of the Bu/Bc methods.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
023410
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use