(59 days)
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No
The device is a calibration verification test set for laboratory chemistry systems and the description and performance data do not mention any AI or ML components.
No
The device is used to verify calibration, validate reportable ranges, and determine linearity in chemistry systems, not to diagnose, treat, or prevent disease in a patient.
No
This device is a calibration verification test set, used to verify the calibration and linearity of chemistry systems. It does not diagnose a patient's condition but rather ensures the accuracy of laboratory equipment.
No
The device description clearly states it is an "aqueous based calibration verification test set containing multiple levels" and comes in "bottles," indicating it is a physical reagent kit, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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 analyte: uric acid." This describes a process performed in vitro (outside the body) on samples (presumably patient samples, although not explicitly stated, the context of chemistry systems implies this) to ensure the accuracy of diagnostic tests.
- Device Description: The description of the device as an "aqueous based calibration verification test set containing multiple levels" further supports its use in a laboratory setting for quality control of diagnostic instruments.
- Performance Studies: The performance studies compare the device to a predicate device (DOCUMENT Uric Acid CAL-VER) which is also likely an IVD used for similar purposes. The metrics reported (Correlation Coefficient, Regression Equation) are typical for evaluating the performance of calibration and verification materials used in diagnostic testing.
While the document doesn't explicitly state it's used with patient samples, the context of "chemistry systems" and "calibration verification" for an analyte like uric acid strongly indicates its role in ensuring the accuracy of diagnostic tests performed on biological samples. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VALIDATE Chem 6 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: uric acid.
Product codes
JJX
Device Description
VALIDATE Chem 6 Calibration Verification Test Set is an agueous based calibration verification test set containing multiple levels used to 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained laboratory professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Linear regression analysis was carried out on recovered values for uric acid. The analyte was tested in triplicate. The VALIDATE Chem 6 Calibration Verification andition was been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Uric Acid CAL•VER.
Key Metrics
Correlation Coefficient (r) for VALIDATE Chem 6 Calibration Verification Test Set for UA was 0.99995.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 1 6 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: Kol3119
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: September 11, 2001
Proprietary Name: | VALIDATE Chem 6 Calibration Verification Test Set |
---|---|
Common Name: | Calibration Verification |
Classification Name: | Calibrator, Single Analyte |
Predicate Devices:
- DOCUMENT Uric Acid CAL-VER, K893139, manufactured by CASCO 1. NERL Diagnostics.
Device description: VALIDATE Chem 6 Calibration Verification Test Set is an agueous based calibration verification test set containing multiple levels used to 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 6 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: uric acid.
1
Comparison of VALIDATE Chem 6 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 6 Calibration Verification Test Set with those of the DOCUMENT Uric Acid CAL.•VER.
| | VALIDATE CHEM 6
Calibration Verification Test
Set | DOCUMENT
Uric Acid CAL•VER |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10006 | M-106 |
| 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 | Uric Acid | Uric Acid |
| Matrix | aqueous | aqueous |
| Number of
Levels | 6 including Zero | 5 |
| Preparation | Liquid,
ready to use | Liquid,
ready to use |
| Packaging | 5.0 mL each level | 5.0 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 6 Calibration Verification Test Set solutions on the Beckman Synchron CX instrument system as compared to DOCUMENT Uric Acid CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 6 Calibration Verification Test Sets. The results of correlation comparisons between the VALIDATE Chem 6 Calibration Verification Test Set and the predicate device are presented in Table 2.
2
Linear Regression Statistical Comparison of VALIDATE Chem 5 TABLE 2. Calibration Verification Test Set to the predicate device.
| | VALIDATE
Chem 6
Calibration Verification Test Set | | DOCUMENT
Uric Acid
CAL·VER | |
|---------|---------------------------------------------------------|-----------------------------------------------|-----------------------------------|-----------------------------------------------|
| Analyte | Correlation
Coefficient (r) | Regression Equation
Y=intercept + slope(X) | Correlation
Coefficient
(r) | Regression Equation
Y=intercept + slope(X) |
| UA | 0.99995 | $.031 + .956(x)$ | 0.99996 | $.155 + .91(x)$ |
Summary:
Linear regression analysis was carried out on recovered values for uric acid. The analyte was tested in triplicate. The VALIDATE Chem 6 Calibration Verification andition was been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Uric Acid CAL•VER.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 6 2001
Ms. Christine Beach Manager, RA/QA Maine Standards Company 765 Roosevelt Trail Windham, ME 04062
K013119 Re:
Trade/Device Name: VALIDATE Chem 6 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 - 862.1660 - 862.1775 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: I Reserved Product Code: JJX Dated: September 11, 2001 Received: September 18, 2001
Dear Ms. Beach:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have love 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 mendments, 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 the general of 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.
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 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 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 1 6 2001
INDICATIONS FOR USE STATEMENT
510(k) Number: Kol3119
Device Name: VALIDATE Chem 6 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 6 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 analyte: uric acid.
Jean Cooper
(Division Si
Division of (
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
t
Over-The-Counter Use