(38 days)
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No
The summary describes a calibration verification test set for chemistry systems, focusing on chemical composition and performance verification against predicate devices using linear regression. There is no mention of AI or ML.
No
This device is a calibration verification test set for laboratory instruments, not a device used for treating patients.
No
This device is a calibration verification test set, used to verify the calibration and validate reportable ranges of automated chemistry systems. It does not directly diagnose a patient's condition.
No
The device description clearly states it contains purified chemicals in an aqueous base, indicating it is a physical product (a test set) and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's used 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." This describes a process performed in vitro (outside the body) on samples (presumably patient samples, although not explicitly stated, the context of "automated chemistry systems" implies this) to ensure the accuracy of diagnostic measurements.
- Device Description: The device contains "purified chemicals in an aqueous base" and is used to "establish the relationship between theoretical operation and actual performance of each of the included analytes." This aligns with the nature of calibration and verification materials used in laboratory testing.
- Performance Studies: The performance studies compare the device to a "DOCUMENT Direct ISE CAL•VER," which is a predicate device used for calibration verification. This further reinforces its role in the quality control of diagnostic testing.
- Predicate Device: The presence of a predicate device (K881773, DOCUMENT Direct ISE CAL-VER) which is also a calibration verification material, strongly indicates that this device falls under the same regulatory category, which for these types of products is IVD.
While the document doesn't explicitly use the term "IVD," the intended use, device description, and comparison to a known IVD predicate device clearly indicate that the VALIDATE Chem 8 Calibration Verification Test Set is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The VALIDATE Chem 8 Calibration Verification Test Set is used by trained
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Li: Correlation Coefficient (r) = 1.0 (VALIDATE Chem 8 Calibration Verification Test Set), 1.0 (DOCUMENT Direct ISE CAL•VER)
Regression Equation Y=intercept + slope(X): 1.0011x - 0.0102 (VALIDATE Chem 8 Calibration Verification Test Set), 1.0162x - 0.0685 (DOCUMENT Direct ISE CAL•VER)
NA: Correlation Coefficient (r) = 1.0 (VALIDATE Chem 8 Calibration Verification Test Set), 0.9999 (DOCUMENT Direct ISE CAL•VER)
Regression Equation Y=intercept + slope(X): x + 0.0867 (VALIDATE Chem 8 Calibration Verification Test Set), 1.0437x + 0.1 (DOCUMENT Direct ISE CAL•VER)
K: Correlation Coefficient (r) = 0.9999 (VALIDATE Chem 8 Calibration Verification Test Set), 0.9999 (DOCUMENT Direct ISE CAL•VER)
Regression Equation Y=intercept + slope(X): 1.0004x - 0.0607 (VALIDATE Chem 8 Calibration Verification Test Set), 1.1243x - 0.2693 (DOCUMENT Direct ISE CAL•VER)
CL: Correlation Coefficient (r) = 0.9998 (VALIDATE Chem 8 Calibration Verification Test Set), 0.9996 (DOCUMENT Direct ISE CAL•VER)
Regression Equation Y=intercept + slope(X): 1.0047x - 0.0248 (VALIDATE Chem 8 Calibration Verification Test Set), 0.9601x + 7.5 (DOCUMENT Direct ISE CAL•VER)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company LLC. The words "maine" and "standards" are separated by a diagonal line. Below "standards" is the text "COMPANY LLC". To the right of the logo is the text "MAR 21".
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 Trail |
| Windham, 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 8
Calibration Verification Test Set | DOCUMENT
Direct ISE CAL•VER |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 108 | M-101 |
| Intended Use | For in vitro diagnostic use in
quantitatively verifying calibration,
validating reportable ranges, and
determining linearity in automated,
semi-automated and manual
chemistry systems. | For in vitro diagnostic use in the
quantitative determination of
linearity in manual, automated
and semi-automated chemistry
systems. |
| Analytes | Li, NA, K, CL | Li, NA, K, CL |
| Matrix | aqueous | aqueous |
| Number of
Levels | 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. |
| | VALIDATE
Chem 8
Calibration Verification Test Set | | DOCUMENT
Direct ISE
CAL·VER | |
|---------|---------------------------------------------------------|-----------------------------------------------|-----------------------------------|-----------------------------------------------|
| Analyte | Correlation Coefficient
(r) | Regression Equation
Y=intercept + slope(X) | Correlation Coefficient
(r) | Regression Equation
Y=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
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