(45 days)
The VALIDATE Chem 3 Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: total protein, albumin, cholesterol and iron.
The VALIDATE Chem 3 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: total protein, albumin, cholesterol, and iron.
VALIDATE Chem 3 Calibration Verification Test Set is a liquid, human serum based calibration verification test set containing multiple levels used establish the relationship between theoretical operation and actual performance of each of the included analytes Each set contains one bottle each of six (6) ievels, including zero. Each bottle contains 5 milliliters.
The provided document describes the VALIDATE Chem 3 Calibration Verification Test Set and its substantial equivalence to predicate devices. Here's an analysis of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the VALIDATE Chem 3 Calibration Verification Test Set in terms of pre-defined thresholds for correlation coefficients or regression equations. Instead, it demonstrates substantial equivalence to predicate devices by comparing their performance.
The implicit acceptance criterion for this 510(k) submission is that the performance of the VALIDATE Chem 3 device on a specific instrument system (Roche Diagnostics Hitachi 911) should show strong correlation and similar regression characteristics to the predicate devices.
| Analyte | Acceptance Criteria (Implicit - Strong Correlation to Predicate) | Reported VALIDATE Chem 3 Performance (Correlation Coefficient r) | Reported VALIDATE Chem 3 Performance (Regression Equation Y=intercept + slope(X)) |
|---|---|---|---|
| TP | Strong correlation to predicate TP (DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER) | 0.99984 | .109 + .969 |
| ALB | Strong correlation to predicate ALB (DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER) | 0.99920 | .022 + 1.025 |
| CHOL | Strong correlation to predicate CHOL (DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER) | 0.99998 | 2.117 + .988 |
| FE | Strong correlation to predicate FE (DOCUMENT Iron / Magnesium / Triglyceride CAL•VER) | 0.99950 | -7.942 + .996 |
Study Proving Device Meets Acceptance Criteria:
A "Linear Regression Statistical Comparison" study was conducted to demonstrate the substantial equivalence of the VALIDATE Chem 3 Calibration Verification Test Set to the predicate devices.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document states that "Each analyte was tested in triplicate." For each analyte (Total Protein, Albumin, Cholesterol, Iron), the VALIDATE Chem 3 test set contains six levels (including zero). Therefore, the total number of measurements for each analyte from the VALIDATE Chem 3 device would be 6 levels * 3 replicates = 18 data points. Similar testing was presumably done for the predicate devices to generate the comparison data.
- Data Provenance: The study was conducted using "pre-production lots" of the VALIDATE Chem 3 Calibration Verification Test Set. The country of origin of the data is not explicitly stated, but the company (Maine Standards Company, LLC) is based in the USA, suggesting the study was likely conducted domestically. The study is prospective in the sense that it used pre-production lots to generate new data for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of study (calibration verification/linearity assessment) does not typically involve human experts establishing ground truth in the same way an image analysis study would. The ground truth here is the performance of the predicate devices and the expectation that a new device designed for the same purpose on the same instrument should yield highly correlated results. The "ground truth" for the linearity and calibration verification aspects are the known, expected values for each level of the calibrator and the inherent accuracy and precision of the instrument system itself.
4. Adjudication method for the test set
Not applicable for this type of in vitro diagnostic device study. The comparison is statistical (linear regression) rather than expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This study evaluates the performance of the device (calibration verification test set) on an automated instrument system (Roche Diagnostics Hitachi 911). So, in essence, it is an "algorithm only" or "device-only" performance evaluation as it assesses the chemical performance and linearity of the calibrator solutions on the instrument. There is no human-in-the-loop performance being evaluated in this context, other than the initial setup and reading of the instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this study is essentially the established performance and linearity of the predicate devices on the specified instrument system, as well as the theoretical true values of the analytes in robust calibrator materials. The study aims to show that the new device's measurements align with these established "truths" through strong statistical correlation.
8. The sample size for the training set
This document does not describe a machine learning algorithm or a "training set" in that context. The device is a chemical calibrator.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for this type of device.
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MAINE STANDARDS COMPANY, LLC
AUG 2 0 2001
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: KOI@ II 9
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt Trail Windham, ME 04062 |
| Telephone: | 207-892-1300 |
| Fax: | 207-892-2266 |
| Contact: | Christine Beach, Mgr. RA/QA |
Summary prepared on: June 29, 2001
| Proprietary Name: | VALIDATE Chem 3 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Devices:
- DOCUMENT Total Protein/Albumin/Cholesterol CAL-VER, K883861, 1. manufactured by CASCO NERL Diagnostics.
-
- DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, manufactured by CASCO NERL Diagnostics.
Device description: VALIDATE Chem 3 Calibration Verification Test Set is a liquid, human serum based calibration verification test set containing multiple levels used establish the relationship between theoretical operation and actual performance of each of the included analytes Each set contains one bottle each of six (6) ievels, including zero. Each bottle contains 5 milliliters.
Intended use: VALIDATE Chem 3 Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: total protein, albumin, cholesterol and iron.
Office location · 765 Roosevelt Trail · Windham, Maine 04062 Mailing address · P.O. Box 8360 · Portland, ME 04104-8360 Tel. 207-892•1300 • Fax 207•892•2266 • Toll Free 800•377•9684
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Comparison of VALIDATE Chem 3 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 3 Calibration Verification Test Set with those of the DOCUMENT Iron / Magnesium / Triglyceride CAL�VER, DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER.
| VALIDATE CHEM 3CalibrationVerification Test Set | DOCUMENT TotalProtein / Albumin /Cholesterol CAL•VER | DOCUMENTIron, Magnesium,TriglycerideCAL•VER | |
|---|---|---|---|
| Catalog # | 10003 | M-102 | M-103 |
| Intended Use | For in vitro diagnosticuse in quantitativelyverifying calibration,validating reportableranges, anddetermining linearity inautomated, semi-automated and manualchemistry systems. | For in vitro diagnosticuse in the quantitativedetermination oflinearity in manual,automated and semi-automated chemistrysystems. | For in vitro diagnosticuse in the quantitativedetermination oflinearity in manual,automated and semi-automated chemistrysystems. |
| Analytes | TP, ALB, CHOL, FE | TP, ALB, CHOL | FE |
| Matrix | protein | protein | aqueous |
| Number ofLevels | 6 including Zero | 5 | 5 |
| Preparation | Liquid,ready to use | Liquid,ready to use | Liquid,ready to use |
| Packaging | 5.0 mL each level | 8.0 mL each level | 10.0 mL each level |
| Stability | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C | 2-8°C |
Comparison of Products TABLE 1.
The performance of VALIDATE Chem 3 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Iron / Magnesium / Triglyceride CAL . VER, DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 3 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 3 Calibration Verification Test Set and the predicate devices are presented in Table 2.
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TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 3 Calibration Verification Test Set to the predicate devices.
| VALIDATEChem 3Calibration VerificationTest Set | DOCUMENTTotal Protein / Albumin /CholesterolCAL·VER | DOCUMENTIron, Magnesium,TriglycerideCAL·VER | ||||
|---|---|---|---|---|---|---|
| Analyte | CorrelationCoefficient(r) | RegressionEquationY=intercept +slope(X) | CorrelationCoefficient(r) | RegressionEquationY=intercept +slope(X) | CorrelationCoefficient(r) | RegressionEquationY=intercept +slope(X) |
| TP | 0.99984 | .109 + .969 | 0.99997 | .125 + .982 | N/A | N/A |
| ALB | 0.99920 | .022 + 1.025 | 0.99856 | .502 + .874 | N/A | N/A |
| CHOL | 0.99998 | 2.117 + .988 | 0.99997 | -3.359 + 1.016 | N/A | N/A |
| FE | 0.99950 | -7.942 + .996 | N/A | N/A | 0.99992 | -3.464 + 1.021 |
Summary:
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Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 3 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL•VER, DOCUMENT Total Protein/Albumin/Cholesterol CAL•VER.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 0 2001
Ms. Christine V. Beach Manager, RA/QA Maine Standards Company, LLC 765 Roosevelt Trail Windham, ME 04062
Re: 510(k) Number: K012119 Trade/Device Name: VALIDATE Chem 3 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I Product Code: JJY Dated: July 3, 2001 Received: July 6, 2001
Dear Ms. Beach:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical-Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: Kola119
Device Name: VALIDATE Chem 3 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 3 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: total protein, albumin, cholesterol, and iron.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) X OR Over-The-Counter Use
Kesia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K012119
§ 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.