(88 days)
The 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.
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.
Here's a breakdown of the acceptance criteria and the study details for the VALIDATE Chem 10 Calibration Verification Test Set, based specifically on the provided text:
Executive Summary:
The VALIDATE Chem 10 Calibration Verification Test Set is a multi-analyte calibrator intended for in vitro diagnostic use to verify calibration, validate reportable ranges, and determine linearity for various chemistry systems. The device's performance was compared to two predicate devices (DOCUMENT Reflectance II Test Set and Ortho-Clinical Diagnostics VITROS Calibrator Kit 4) through linear regression analysis. The study demonstrated functional equivalence for calibration verification and linearity assessment.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "r > 0.99"). Instead, the study aims to show "functional equivalence" to the predicate devices through strong linear correlation. The reported device performance is presented as the correlation coefficients (r) and regression equations. A correlation coefficient close to 1 would indicate substantial equivalence.
| Analyte | Acceptance Criteria (Implied) | VALIDATE Chem 10 Performance (Correlation Coefficient, r) |
|---|---|---|
| ALP | Strong linear correlation with predicate devices | 0.9973 (vs. Predicate 1) |
| ALT | Strong linear correlation with predicate devices | 0.9995 (vs. Predicate 1) |
| AMY | Strong linear correlation with predicate devices | 0.9983 (vs. Predicate 1) |
| AST | Strong linear correlation with predicate devices | 0.9990 (vs. Predicate 1) |
| CK | Strong linear correlation with predicate devices | 0.9932 (vs. Predicate 1) |
| GGT | Strong linear correlation with predicate devices | 0.9975 (vs. Predicate 1) |
| LD | Strong linear correlation with predicate devices | 0.9997 (vs. Predicate 1) |
| LIP | Strong linear correlation with predicate devices | 0.9999 (vs. Predicate 1) |
| TBIL | Strong linear correlation with predicate devices | 0.9999 (vs. Predicate 2) |
| Bu (Bilirubin) | Strong linear correlation with predicate devices | 0.999 (vs. Predicate 2) |
| Bc (Bilirubin) | Strong linear correlation with predicate devices | 0.9995 (vs. Predicate 2) |
Note: The regression equations are also part of the reported performance, showing the relationship between the VALIDATE Chem 10 and the predicate devices. The phrase "functional equivalence" is the overarching acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the VALIDATE Chem 10 Calibration Verification Test Set contains five (5) levels for each analyte. For the predicate device Ortho-Clinical Diagnostics VITROS Calibrator Kit 4, it mentions 3 levels for TBIL and 4 levels for Bu/Bc. It also states "2 x 2.0 mL each level" for the DOCUMENT Reflectance II Test Set, but does not explicitly state the number of levels for this predicate. The study compared "pre-production lots" of the VALIDATE Chem 10. The exact number of individual measurements or "samples" taken for each level across all analytes is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin for the data. It is a retrospective comparison study against predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device (calibration verification materials) does not use "experts" to establish a ground truth in the way a diagnostic imaging device would. The "ground truth" for these materials is their precisely manufactured, known concentrations, which are then run on a clinical chemistry system and compared to the results obtained from predicate devices. The study compares the performance of the new device against established, legally marketed predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of results. The comparison is analytical, based on statistical correlation of measured values.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images). This device is a quality control material, and its performance is evaluated through analytical comparison.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done in the sense that the new device's analytical performance was assessed independently by running it on the Ortho-Clinical Diagnostics VITROS instrument system and then comparing its results to those obtained from the predicate devices through linear regression analysis. There is no "human-in-the-loop" component to the device's function or the primary performance study described.
7. Type of Ground Truth Used
The ground truth for this device is the known, precisely manufactured concentrations of the analytes within the calibration verification test set, as well as the established performance of the legally marketed predicate devices. The study then assesses how well the new device's measured values correlate with those of the predicate devices on a target instrument system.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It is a manufactured reagent product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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.
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Comparison to Predicate Devices:
| VALIDATE CHEM 10Calibration VerificationTest Set | DOCUMENTReflectance IITest Set | Ortho-ClinicalDiagnostics VITROSCalibrator Kit 4 | |
|---|---|---|---|
| Catalog # | 110 | R-102 | 1204668 |
| Intended Use | For in vitro diagnostic usein quantitatively verifyingcalibration, validatingreportable ranges, anddetermining linearity inautomated, semi-automated and manualchemistry systems. | For in vitro diagnosticuse in thequantitativedetermination oflinearity in manual,automated and semi-automated chemistrysystems. | For use in thecalibration of VITROSchemistry systems forthe quantitativemeasurementof total and directbilirubin. |
| 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 ofLevels | 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 afterreconstitution |
| 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.
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| Table 2. | Linear Regression Statistical Comparison between VALIDATE Chem |
|---|---|
| 10 Calibration Verification Test Set and the predicate devices. |
| VALIDATEChem 10Calibration Verification Test Set | DOCUMENTReflectance II Test Set | |||
|---|---|---|---|---|
| Analyte | CorrelationCoefficient(r) | Regression EquationY = slope(X) + intercept | CorrelationCoefficient(r) | Regression EquationY = 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 |
| VALIDATEChem 10Calibration Verification Test Set | Ortho-Clinical Diagnostics VITROSCalibrator Kit 4 | |||
|---|---|---|---|---|
| Analyte | CorrelationCoefficient(r) | Regression EquationY = slope(X) + intercept | CorrelationCoefficient(r) | Regression EquationY = 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.
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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).
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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 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
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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
§ 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.