(50 days)
The VALIDATE Chem 7 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: iron, creatinine, ammonia, and ethanol.
VALIDATE Chem 7 Calibration Verification Test Set is an aqueous 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.
The provided text describes the VALIDATE Chem 7 Calibration Verification Test Set and its comparison to predicate devices, but it does not explicitly state acceptance criteria in numerical thresholds or specific performance metrics other than correlation coefficients.
The study aims to demonstrate substantial equivalence to existing predicate devices, rather than meeting specific predefined performance targets set by the manufacturer. The core of the "acceptance criteria" here is that the device's performance is comparable to that of the previously cleared predicate devices.
Here's the information requested, based on the provided text, with acknowledgments of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit numerical acceptance criteria for correlation coefficient, beyond demonstrating "functional equivalence" to predicate devices, are not provided. The acceptance criterion is implicit: the device's performance (correlation coefficient and regression equation) should be similar to or better than that of the predicate devices.
| Analyte | Characteristic/Metric | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | VALIDATE Chem 7 Reported Performance | Predicate Device Reported Performance (Example: DOCUMENT Iron, Magnesium, Triglyceride CAL•VER) |
|---|---|---|---|---|
| Iron (FE) | Correlation Coefficient (r) | "Functionally equivalent" to predicate device's r | 0.99997 | 0.99979 |
| Regression Equation | "Functionally equivalent" to predicate device's result | Y = 0.327 + 1.001X | Y = -5.539 + 1.007X | |
| Creatinine (CRE) | Correlation Coefficient (r) | "Functionally equivalent" to predicate device's r | 0.99952 | 0.99987 (from DOCUMENT Multi-Analyte CAL•VER) |
| Regression Equation | "Functionally equivalent" to predicate device's result | Y = 0.091 + 0.983X | Y = -0.099 + 1.007X (from DOCUMENT Multi-Analyte CAL•VER) | |
| Ammonia (NH3) | Correlation Coefficient (r) | "Functionally equivalent" to predicate device's r | 0.99994 | 0.99809 (from DOCUMENT Ammonia/Ethanol CAL•VER) |
| Regression Equation | "Functionally equivalent" to predicate device's result | Y = -0.363 + 1.019X | Y = -11.616 + 1.074X (from DOCUMENT Ammonia/Ethanol CAL•VER) | |
| Ethanol (ETOH) | Correlation Coefficient (r) | "Functionally equivalent" to predicate device's r | 0.99998 | 0.99872 (from DOCUMENT Ammonia/Ethanol CAL•VER) |
| Regression Equation | "Functionally equivalent" to predicate device's result | Y = -0.159 + 1.009X | Y = -1.261 + 1.04X (from DOCUMENT Ammonia/Ethanol CAL•VER) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): The document states that the analytes were "tested in triplicate" for the linear regression analysis. It also mentions "six (6) levels, including zero" for the device. Therefore, the test set likely involved 6 levels * 3 replicates = 18 measurements for each analyte to generate the linear regression data. The predicate devices also use 5 levels.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that the study used "pre-production lots of VALIDATE Chem 7 Calibration Verification Test Set" on a "Beckman CX instrument system". The study appears to be prospective in nature, as it involved testing pre-production lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a calibration verification test set, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for linearity and calibration verification in this context is established by the known concentrations/relationships of the levels within the test sets themselves and the analytical methods used to measure them on the instrument.
4. Adjudication method for the test set
Not applicable. As noted above, this study does not involve expert adjudication as it is a performance study for a calibration verification material on an instrument, not a diagnostic interpretation study.
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 a diagnostic imaging or reader study. It is a performance study for an in vitro diagnostic (IVD) calibrator/control material. The concept of "human readers" or "AI assistance" is irrelevant to the function of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the study is a "standalone" or "algorithm only" performance evaluation of the VALIDATE Chem 7 Calibration Verification Test Set, where the "algorithm" is the chemistry analyzer (Beckman CX instrument system) measuring the prepared samples. There is no human interpretation involved in the measurement process itself, only in the setup and analysis of the data.
7. The type of ground truth used
The ground truth is based on the known, manufactured concentrations/relationships specified for the calibration verification material and the analytical measurement principles of the Beckman CX instrument system. The study compares the new device's response curve to that of already accepted predicate devices.
8. The sample size for the training set
Not applicable. This device is a chemical calibrator, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of the calibration verification material and its characterization would involve its own internal validation, but that is distinct from a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the calibrator material itself would be established through precise manufacturing processes, metrological traceability (if applicable), and analytical methods to ensure the stated concentrations/relationships of the levels are accurate.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company LLC. The logo is divided by a diagonal line, with "maine" on the top left and "standards" on the bottom right. The text "NOV 20 2001" is also visible on the right side of the image.
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: September 27, 2001
| Proprietary Name: | VALIDATE Chem 7 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Devices:
- DOCUMENT Iron/Magnesium/Triglyceride 1. CAL-VER. K893142. manufactured by CASCO NERL Diagnostics.
-
- DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by CASCO-NERL Diagnostics.
- DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by 3. CASCO-NERL Diagnostics.
Device description: VALIDATE Chem 7 Calibration Verification Test Set is an aqueous 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.
Intended use: VALIDATE Chem 7 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: iron, creatinine, ammonia, and ethanol.
7 6 5 R O O S E V E L T T A I L . W I N D H A M , M A I N E 0 4 0 6 2 TEL:207.892.1300 · FAX:207.892.2266 · TOLL-FREE:800.377.968 www.mainestandards.com
{1}------------------------------------------------
Comparison of VALIDATE Chem 7 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 7 Calibration Verification Test Set with those of the DOCUMENT Iron/Magnesium/Triglyceride CAL�VER, Multi-Analyte CAL.VER, and DOCUMENT Ammonia/Ethanol DOCUMENT CAL·VER.
| VALIDATECHEM 7CalibrationVerificationTest Set | DOCUMENTIron,Magnesium,TriglycerideCAL•VER | DOCUMENTMulti-AnalyteCAL•VER | DOCUMENTAmmonia /EthanolCAL•VER | |
|---|---|---|---|---|
| Catalog # | 10007 | M-103 | M-100 | M-108 |
| IntendedUse | For in vitrodiagnostic use inquantitativelyverifyingcalibration,validatingreportableranges, anddetermininglinearity inautomated, semi-automated andmanualchemistrysystems. | For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems. | For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems. | For in vitrodiagnostic use inthe quantitativedetermination oflinearity inmanual,automated andsemi-automatedchemistrysystems. |
| Analytes | FE, CRE, NH3,ETOH | FE, MG, TRIG | GLU, BUN, NA,K, CL, CRE, CA,PO4 | NH3, ETOH |
| Matrix | aqueous | aqueous | aqueous | aqueous |
| Number ofLevels | 6 including Zero | 5 | 5 | 5 |
| Preparation | Liquid,ready to use | Liquid,ready to use | Liquid,ready to use | Liquid,ready to use |
| Packaging | 5.0 mL eachlevel | 10.0 mL eachlevel | 15 mL each level | 3.0 mL eachlevel |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C | 18-25°C | 2-8°C |
| TABLE 1. | Comparison of Products |
|---|---|
| ---------- | ------------------------ |
The performance of VALIDATE Chem 7 Calibration Verification Test Set solutions Beckman CX instrument system as compared to DOCUMENT on the Iron/Magnesium/Triglyceride CAL•VER, DOCUMENT Multi-Analyte CAL•VER, and DOCUMENT Ammonia/Ethanol CAL.•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 7 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 7 Calibration Verification Test Set and the predicate device are presented in Table 2.
{2}------------------------------------------------
- TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 7 Calibration Verification Test Set to the predicate devices.
| VALIDATEChem 7Calibration Verification Test Set | DOCUMENTIron, Magnesium, TriglycerideCAL•VER | |||
|---|---|---|---|---|
| Analyte | CorrelationCoefficient (r) | Regression EquationY = intercept + slope(X) | CorrelationCoefficient(r) | Regression EquationY = intercept + slope(X) |
| FE | 0.99997 | .327 + 1.001X | 0.99979 | -5.539 + 1.007X |
| VALIDATEChem 7Calibration Verification Test Set | DOCUMENTMulti-AnalyteCAL•VER | |||
| Analyte | CorrelationCoefficient (r) | Regression EquationY = intercept + slope(X) | CorrelationCoefficient (r) | Regression EquationY = intercept + slope(X) |
| CRE | 0.99952 | .091 + .983X | 0.99987 | -.099 + 1.007X |
| VALIDATEChem 7Calibration Verification Test Set | DOCUMENTAmmonia/EthanolCAL·VER | |||
|---|---|---|---|---|
| Analyte | CorrelationCoefficient (r) | Regression EquationY = intercept + slope(X) | CorrelationCoefficient(r) | Regression EquationY = intercept + slope(X) |
| NH3 | 0.99994 | -.363 + 1.019X | 0.99809 | -11.616 + 1.074X |
| ETOH | 0.99998 | -.159 + 1.009X | 0.99872 | -1.261 + 1.04X |
Summary:
Linear regression analysis was carried out on recovered values for iron, creatinine, ammonia, and ethanol. The analytes were tested in triplicate. The VALIDATE Chem 7 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 Multi-Analyte CAL•VER, and DOCUMENT Ammonia/Ethanol CAL•VER.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Christine Beach Manager RA/QA Maine Standards Company 765 Roosevelt Trail Windham, ME 04062
NOV 2 0 2001
K013265 Re:
R013205
Trade/Device Name: VALIDATE Chem 7 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: September 27, 2001 Received: October 1, 2001
Dear Ms. Beach:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your 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 for use sualed in the encreating of the enactment date of the Medical Device Amendments, or to conimores prior to ria) 20, 20, 20, 20, 2017 11:25 provisions of the Federal Food, Drug, de nees that have been route approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , there core, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or babyer to oach as out Federal Regulations, Title 21, Parts 800 to 898. 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 r loase of actived that i Drivination that your device complies with other requirements of the Act that I Dri has made a avad regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
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 nredicate 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 Sutman
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
{5}------------------------------------------------
NOV 2 0 2001
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: VALIDATE Chem 7 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 7 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; iron, creatinine, ammonia, 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 and ethanol. STIN
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013265
Concurrence of CDRH, Office of Device Evaluation (ODE)
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.