(45 days)
The VALIDATE Chem 5 Calibration Verification Test Set is used by trained I the VALIDATE onomals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: iron.
VALIDATE Chem 5 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 the included analyte Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.
Here's a breakdown of the acceptance criteria and the study details for the VALIDATE Chem 5 Calibration Verification Test Set, based on the provided 510(k) summary:
This device is not an AI/ML device but rather a calibration verification test set used in clinical chemistry. Therefore, many of the requested fields related to AI performance, such as MRMC studies, human reader improvement with AI, and standalone algorithm performance, are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (VALIDATE Chem 5) | Relevant Section |
|---|---|---|
| Analyte Equivalence | Demonstrated substantial equivalence to predicate device for Iron (FE). | Section 2, Table 2 |
| Correlation Coefficient (for Iron) | 0.99999 (compared to predicate's 0.99992) | Section 2, Table 2 |
| Regression Equation (for Iron) | 1.498 + 0.992(X) (compared to predicate's -3.464 + 1.021(X)) | Section 2, Table 2 |
| Functional Equivalence | "Has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL•VER." | Section 2, Summary |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "The analyte was tested in triplicate." This refers to each level of the calibration verification test set, but not a total number of patient samples. For a calibration verification device, the "sample" is the reference material itself. There are 6 levels for the VALIDATE Chem 5.
- Data Provenance: Not explicitly stated, but the study was conducted internally by Maine Standards Company using pre-production lots of their own device. As it's a calibration material, geographical origin of "data" in the sense of patient samples is not relevant. The testing was done on a specific instrument system (Roche Diagnostics Hitachi 911).
- Retrospective/Prospective: Not applicable in the traditional sense for a calibration material. The testing involves running the calibration material on an instrument.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For a calibration verification test set, the "ground truth" (i.e., the true concentration of the analyte at each level) is established through rigorous analytical methods and traceability to reference standards, not by expert interpretation. The purpose of these materials is to verify the performance of an instrument, not to be interpreted by an expert.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication is typically used for subjective clinical interpretations (e.g., image reading) where disagreement among experts might occur. This is a quantitative analytical device.
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 not an AI/ML device, nor does it involve human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device with an algorithm for diagnosis or prediction.
7. The Type of Ground Truth Used
- Reference Standards/Certified Values. For calibration verification materials, the "ground truth" for each level's analyte concentration is established through highly accurate analytical methods, often traceable to international reference standards, by the manufacturer. The document doesn't explicitly detail the method for establishing these values but states it's for "quantitatively verifying calibration," implying a known, reference value for each level.
8. The Sample Size for the Training Set
- Not Applicable. This device does not use machine learning, therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.
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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: ________ "
| Submitter: | Maine Standards Company |
|---|---|
| Address: | 765 Roosevelt TrailWindham, 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 5 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Devices:
- DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, 1. manufactured by CASCO NERL Diagnostics.
Device description: VALIDATE Chem 5 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 the included analyte Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.
Intended use: VALIDATE Chem 5 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 analyte: iron.
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Comparison of VALIDATE Chem 5 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 5 Calibration Verification Test Set with those of the DOCUMENT Iron/Magnesium/Triglyceride CAL.�VER.
| VALIDATE CHEM 3Calibration Verification TestSet | DOCUMENTIron, Magnesium, TriglycerideCAL·VER | |
|---|---|---|
| Catalog # | 10003 | M-103 |
| Intended Use | For in vitro diagnostic use inquantitatively verifyingcalibration, validating reportableranges, and determininglinearity in automated, semi-automated and manualchemistry systems. | For in vitro diagnostic use in thequantitative determination oflinearity in manual, automatedand semi-automated chemistrysystems. |
| Analytes | FE | FE |
| Matrix | aqueous | aqueous |
| Number ofLevels | 6 including Zero | 5 |
| Preparation | Liquid,ready to use | Liquid,ready to use |
| Packaging | 5.0 mL each level | 10.0 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C |
Comparison of Products TABLE 1.
The performance of VALIDATE Chem 5 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Iron/Magnesium/Triglyceride CAL.�VER, has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 5 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 5 Calibration Verification Test Set and the predicate device are presented in Table 2.
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TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 5 Calibration Verification Test Set to the predicate devices.
| VALIDATEChem 5Calibration Verification Test Set | DOCUMENTIron, Magnesium, TriglycerideCAL•VER | |||
|---|---|---|---|---|
| Analyte | Correlation Coefficient (r) | Regression EquationY=intercept + slope(X) | Correlation Coefficient (r) | Regression EquationY=intercept + slope(X) |
| FE | 0.99999 | 1.498 + .992 | 0.99992 | -3.464 + 1.021 |
Summary:
Linear regression analysis was carried out on recovered values for iron. The analyte was tested in triplicate. The VALIDATE Chem 5 Calibration Verification Test Set has been shown to be functionally equivalent for calibration venfication and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL•VER.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
AUG 2 0 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Christine V. Beach Manager, RA/QA Maine Standards Company, LLC 765 Roosevelt Trail Windham, ME 04062
510(k) Number: K012122 Re: Trade/Device Name: VALIDATE Chem 5 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I, Reserved Product Code: JJX 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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Page 2 -
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 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 Butman
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: _______________________________________________________________________________________________________________________________________________________________
Device Name: VALIDATE Chem 5 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 5 Calibration Verification Test Set is used by trained I the VALIDATE onomals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analyte: iron.
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\checkmark$ Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Kesia Alexander de Jean Conper
510(k) Number
§ 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.