(38 days)
The VALIDATE Chem 8 Calibration Verification Test Set is used by trained personnel for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems employing direct ion selective technology to measure the following analytes: lithium, sodium, potassium and chloride.
VALIDATE Chem 8 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of five (5) levels. Each bottle contains 3.0 milliliters.
The provided text describes a 510(k) summary for the "VALIDATE Chem 8 Calibration Verification Test Set". This device is an in-vitro diagnostic (IVD) product used for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems that measure specific analytes (lithium, sodium, potassium, and chloride).
The study presented is a comparison of this new device to a predicate device, the "DOCUMENT Direct ISE CAL•VER". The primary goal is to demonstrate "substantial equivalence" to the predicate device.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a calibration verification test set, the acceptance criteria are generally focused on demonstrating linearity and correlation with a reference method or predicate device. The performance is assessed using statistical measures such as correlation coefficients and linear regression equations.
| Acceptance Criteria (Implied) | Reported Device Performance (VALIDATE Chem 8) |
|---|---|
| High Correlation Coefficient (r) with comparison method/predicate device (e.g., close to 1.0) | Lithium (Li): Correlation Coefficient (r) = 1.0, Regression Equation (Y=intercept + slope(X)) = 1.0011x - 0.0102Sodium (NA): Correlation Coefficient (r) = 1.0, Regression Equation (Y=intercept + slope(X)) = x + 0.0867Potassium (K): Correlation Coefficient (r) = 0.9999, Regression Equation (Y=intercept + slope(X)) = 1.0004x - 0.0607Chloride (CL): Correlation Coefficient (r) = 0.9998, Regression Equation (Y=intercept + slope(X)) = 1.0047x - 0.0248 |
| Linear Regression Equation demonstrating functional equivalence (slope near 1, intercept near 0) in comparison to the predicate. | Lithium (Li): Y = 1.0011x - 0.0102 (Predicate: 1.0162x - 0.0685)Sodium (NA): Y = x + 0.0867 (Predicate: 1.0437x + 0.1)Potassium (K): Y = 1.0004x - 0.0607 (Predicate: 1.1243x - 0.2693)Chloride (CL): Y = 1.0047x - 0.0248 (Predicate: 0.9601x + 7.5)Summary statement explicitly states: "VALIDATE Chem 8 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Direct ISE CAL•VER." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states that there are "Multiple levels" provided, and "Each set contains one bottle each of five (5) levels." The study compares the performance "on the AVL 9180 Electrolyte Analyzer, AVL Scientific Corporation, Roswell, GA, for lithium, sodium and potassium and the Beckman Synchron CX, Beckman Coulter, Inc. Fullerton. CA. for chloride as compared to DOCUMENT Direct ISE CAL•VER using pre-production lots of VALIDATE Chem 8 Calibration Verification Test Set."
- This implies a sample size of 5 data points per analyte for the linearity assessment (one for each level).
- Data Provenance:
- Country of Origin: United States (AVL Scientific Corporation, Roswell, GA; Beckman Coulter, Inc. Fullerton, CA; Maine Standards Company, Windham, ME).
- Retrospective or Prospective: Not explicitly stated, but the use of "pre-production lots" and the nature of calibration verification (testing against known values) suggests a prospective experimental setup where the device samples are analyzed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is an in-vitro diagnostic device, not an image analysis or clinical diagnostic device that relies on expert human interpretation for ground truth. The "ground truth" for this device would be the expected analyte concentrations of the calibration verification materials, which are manufactured to specific specifications. Therefore, this question is not applicable in the traditional sense of human experts establishing ground truth. The "ground truth" is derived from the manufacturing and assay of the calibration materials themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device does not involve human interpretation or subjective assessment that would require an adjudication method. The performance is assessed by quantitative measurements and statistical analysis.
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 calibration verification product, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the calibration verification test set itself as measured by the automated chemistry systems. The study presented is a form of standalone performance evaluation for the device, showing its analytical performance (linearity, correlation) when used in the intended automated systems. The device itself (the VALIDATE Chem 8 set) is a reagent, and its "performance" is how accurately it allows the instruments to verify calibration and linearity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this study is the theoretical or target concentrations of the analytes within the VALIDATE Chem 8 Calibration Verification Test Set and the predicate device. These are established during the manufacturing process of the calibration materials. The study then compares the measured values from the automated systems against these known ("ground truth") levels and against the performance of the predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. It is a physical reagent used for calibration verification.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device.
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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 807.92.2
"The assigned 510(k) number is: KOLOUSO
| 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: February 6, 2002
| Proprietary Name: | VALIDATE Chem 8 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Device:
DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics.
Device description: VALIDATE Chem 8 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of five (5) levels. Each bottle contains 3.0 milliliters.
Intended use: VALIDATE Chem 8 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems employing direct ion selective technology to measure the following analytes: lithium, sodium, potassium, and chloride.
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Comparison of VALIDATE Chem 8 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 8 Calibration Verification Test Set with those of DOCUMENT Direct ISE CAL•VER.
| VALIDATE CHEM 8Calibration Verification Test Set | DOCUMENTDirect ISE CAL•VER | |
|---|---|---|
| Catalog # | 108 | M-101 |
| Intended Use | For in vitro diagnostic use inquantitatively verifying calibration,validating reportable ranges, anddetermining linearity in automated,semi-automated and manualchemistry systems. | For in vitro diagnostic use in thequantitative determination oflinearity in manual, automatedand semi-automated chemistrysystems. |
| Analytes | Li, NA, K, CL | Li, NA, K, CL |
| Matrix | aqueous | aqueous |
| Number ofLevels | 5 | 5 |
| Preparation | Liquid,ready to use | Liquid,ready to use |
| Packaging | 3.0 mL each level | 10.0 mL each level |
| Stability | Until Expiration | Until Expiration |
| Storage | 2-8°C | 18-25°C |
Comparison of Products TABLE 1.
The performance of VALIDATE Chem 8 Calibration Verification Test Set solutions on the AVL 9180 Electrolyte Analyzer, AVL Scientific Corporation, Roswell, GA, for lithium, sodium and potassium and the Beckman Synchron CX, Beckman Coulter, Inc. Fullerton. CA. for chloride as compared to DOCUMENT Direct ISE CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 8 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 8 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 8 | |
|---|---|
| Calibration Verification Test Set to the predicate devices. |
| VALIDATEChem 8Calibration Verification Test Set | DOCUMENTDirect ISECAL·VER | |||
|---|---|---|---|---|
| Analyte | Correlation Coefficient(r) | Regression EquationY=intercept + slope(X) | Correlation Coefficient(r) | Regression EquationY=intercept + slope(X) |
| Li | 1.0 | 1.0011x - 0.0102 | 1.0 | 1.0162x - 0.0685 |
| NA | 1.0 | x + 0.0867 | 0.9999 | 1.0437x + 0.1 |
| K | 0.9999 | 1.0004x - 0.0607 | 0.9999 | 1.1243x - 0.2693 |
| CL | 0.9998 | 1.0047x - 0.0248 | 0.9996 | 0.9601x + 7.5 |
Summary:
Linear regression analysis was carried out on recovered values for each analyte. Each Lifical Tegression analysic Mac camou but on Chem 8 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Direct ISE CAL•VER.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 1 2002
Ms. Christine Beach Manager, OA/RA Maine Standards Company 765 Roosevelt Trail - Suite 9A Windham, ME 04062
K020450 Re:
Trade/Device Name: VALIDATE Chem 8 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: February 6, 2002 Received: February 11, 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 11 your de roo is exactive (controls. Existing major regulations affecting your device can be found in the Code of 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/cdrb/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: KOZOYSO________________________________________________________________________________________________________________________________________________________
Device Name: VALIDATE Chem 8 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 8 Calibration Verification Test Set is used by trained The VALIDATE onom o ounditatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems reportable ranges, and determinely more the following analytes: lithium, sodium, potassium and chloride.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number 402 450
2 - 1
§ 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.