VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
Device Facts
| Record ID | K012117 |
|---|---|
| Device Name | VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 |
| Applicant | Maine Standards Co. |
| Product Code | JJY · Clinical Chemistry |
| Decision Date | Aug 20, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
Intended Use
VALIDATE Chem 1 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
Device Story
VALIDATE Chem 1 Calibration Verification Test Set consists of purified chemicals in aqueous base; provided in six levels (including zero) to establish relationship between theoretical operation and actual performance of chemistry analyzers. Used in clinical laboratory settings by trained professionals. Device serves as calibration verification tool; allows healthcare providers to confirm accuracy of reportable ranges and linearity of chemistry systems. By ensuring analyzer performance, device supports reliable diagnostic testing for various metabolic and electrolyte analytes, ultimately benefiting patient care through accurate clinical decision-making.
Clinical Evidence
Bench testing only. Performance evaluated via correlation studies on Roche Hitachi 911 instrument system comparing subject device to multiple predicate devices. Testing performed in triplicate. Results showed high correlation coefficients (r) ranging from 0.99498 to 0.99999 across all analytes (Na, K, Cl, Ca, PO4, GLU, BUN, CRE, TRIG, MG, LI, LAC, NH3, ETOH).
Technological Characteristics
Aqueous-based multi-analyte test set; 6 levels including zero; 5 mL per bottle. Ready-to-use liquid format. Storage 2-8°C. Analyte list: Na, K, Cl, Ca, PO4, GLU, BUN, CRE, TRIG, MG, LAC, NH3, ETOH, Li. No software or electronic components.
Indications for Use
Indicated for use by trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of automated, semi-automated, and manual chemistry systems for sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
Regulatory Classification
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.
Predicate Devices
- DOCUMENT Multi-Analyte CAL-VER (K870252)
- DOCUMENT Direct ISE CAL-VER (K881773)
- DOCUMENT Iron/Magnesium/Triglyceride CAL-VER (K893142)
- DOCUMENT Ammonia/Ethanol CAL-VER (K962629)
Reference Devices
- Precitrol Ethyl Alcohol/Ammonia/Lactate Control (Roche Diagnostics)
Related Devices
- K012118 — VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 · Maine Standards Co. · Aug 20, 2001
- K023352 — VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 · Maine Standards Co. · Nov 22, 2002
- K020450 — VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 · Maine Standards Co. · Mar 21, 2002
- K023410 — VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 · Maine Standards Co. · Jan 6, 2003
- K013265 — VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 · Maine Standards Co. · Nov 20, 2001
Submission Summary (Full Text)
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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: KO12117
| 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: June 29, 2001
| Proprietary Name: | VALIDATE Chem 1 Calibration Verification Test Set |
|----------------------|---------------------------------------------------|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
### Predicate Devices:
- DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by 1. CASCO NERL Diagnostics.
- 2. DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics.
- DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, ని. manufactured by CASCO NERL Diagnostics.
- DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by বাঁ CASCO NERL Diagnostics.
- Precitrol Ethyl Alcohol/Ammonia/Lactate Control, Roche Diagnostics. ട്.
Device description: VALIDATE Chem 1 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 six (6) levels, including zero. Each bottle contains 5 milliliters.
Intended use: VALIDATE Chem 1 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
> Office location . 765 Roosevelt Trail . Windham, Maine 04062 Mailing address • P.O. Box 8360 • Portland, ME 04104-8360 Tel. 207.892.1300 ・ Fax 207.892.2266 ・ Toll Free 800.377.9684
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Comparison of VALIDATE Chem 1 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 1 Calibration Verification Test Set with those of the DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, DOCUMENT Iron, Magnesium, Triglyceride CAL•VER, DOCUMENT Ammonia/Ethanol CAL•VER, and Roche Diagnostics Precitrol Ethyl Alcohol/Ammonia/Lactate Control.
| | VALIDATE<br>CHEM 1<br>Calibration<br>Verification Test<br>Set | DOCUMENT<br>Multi-Analyte<br>CAL·VER | DOCUMENT<br>Direct ISE<br>CAL·VER | DOCUMENT<br>Iron,<br>Magnesium,<br>Triglyceride<br>CAL·VER |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10001 | M-100 | M-101 | M-103 |
| Intended Use | For in vitro<br>diagnostic use in<br>quantitatively<br>verifying<br>calibration,<br>validating<br>reportable<br>ranges, and<br>determining<br>linearity in<br>automated, semi-<br>automated and<br>manual chemistry<br>systems. | For in vitro<br>diagnostic use in<br>the quantitative<br>determination of<br>linearity in<br>manual,<br>automated and<br>semi-automated<br>chemistry<br>systems. | For in vitro<br>diagnostic use in<br>the quantitative<br>determination of<br>linearity in<br>manual,<br>automated and<br>semi-automated<br>chemistry<br>systems. | For in vitro<br>diagnostic use in<br>the quantitative<br>determination of<br>linearity in<br>manual,<br>automated and<br>semi-automated<br>chemistry<br>systems. |
| Analytes | NA, K, CL, CA,<br>PO₄, GLU, BUN,<br>CRE, TRIG, MG,<br>LAC, NH₃<br>ETOH, LI | GLU, BUN, NA,<br>K, CL, CRE, CA,<br>PO₄ | NA, K, CL, LI | MG<br>TRIG |
| Matrix | aqueous | aqueous | aqueous | aqueous |
| Number of<br>Levels | 6 including Zero | 5 | 5 | 5 |
| Preparation | Liquid,<br>ready to use | Liquid,<br>ready to use | Liquid,<br>ready to use | Liquid,<br>ready to use |
| Packaging | 5.0 mL each level | 15.0 mL each<br>level | 10.0 mL each<br>level | 10.0 mL each<br>level |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 18-25°C | 18-25°C | 2-8°C |
#### Comparison of Products TABLE 1.
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## TABLE 1: continued
| | VALIDATE CHEM 1<br>Calibration<br>Verification Test Set | DOCUMENT<br>Ammonia/<br>Ethanol<br>CAL·VER | Roche Diagnostics<br>Precitrol Ethyl<br>Alcohol/Ammonia/<br>Lactate Controls<br>Low and High |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10001 | M-100 | 1775812 / 1775782 |
| Intended Use | For in vitro diagnostic<br>use in quantitatively<br>verifying calibration,<br>validating reportable<br>ranges, and determining<br>linearity in automated,<br>semi-automated and<br>manual chemistry<br>systems. | For in vitro diagnostic<br>use in the quantitative<br>determination of<br>linearity in manual,<br>automated and semi-<br>automated chemistry<br>systems. | For use as an<br>assayed control<br>material to aid in the<br>assessment of day-<br>to-day performance<br>of automated, semi-<br>automated or<br>manual chemistry<br>systems. |
| Analytes | NA, K, CL, CA, PO4,<br>GLU, BUN, CRE, TRIG,<br>MG, LAC, NH3<br>ETOH, LI | NH3<br>ETOH | LAC |
| Matrix | aqueous | aqueous | aqueous |
| Number of<br>Levels | 6 including Zero | 5 | 1 low and 1 high |
| Preparation | Liquid,<br>ready to use | Liquid,<br>ready to use | Liquid,<br>ready to use |
| Packaging | 5.0 mL each level | 3.0 mL each level | 4.0 mL each level |
| Stability | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C | 2-8°C |
The performance of VALIDATE Chem 1 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, DOCUMENT Iron, Magnesium, Triglyceride CAL•VER, DOCUMENT Ammonia/Ethanol CAL•VER, and Roche Diagnostics Precitrol Ethyl Alcohol/Ammonia/Lactate Control has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 1 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 1 Calibration Verification Test Set and the predicate devices are presented in Table 2.
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| | VALIDATE<br>Chem 1<br>Calibration<br>Verification Test Set | | DOCUMENT<br>Multi-Analyte<br>CAL·VER | | DOCUMENT<br>Direct ISE<br>CAL·VER | | DOCUMENT<br>Iron, Magnesium,<br>Triglyceride<br>CAL·VER | |
|---------|------------------------------------------------------------|-----------------------------------------------------|--------------------------------------|-----------------------------------------------------|-----------------------------------|-----------------------------------------------------|---------------------------------------------------------|---------------------------------------------------|
| Analyte | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept<br>+ slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept<br>+ slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept<br>+ slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercer<br>+ slope{X |
| NA | 0.99993 | -2.455 +<br>1.017 | N/A | N/A | 0.99976 | 3.02 +<br>.966 | N/A | N/A |
| K | 0.99964 | -.014 +<br>1.018 | N/A | N/A | 0.99983 | -.014 +<br>.98 | N/A | N/A |
| CL | 0.99998 | -.175 +<br>1.002 | N/A | N/A | 0.99972 | -3.751 +<br>1.017 | N/A | N/A |
| CA | 0.99992 | -.017 +<br>1.007 | 0.99995 | -.609 +<br>1.124 | N/A | N/A | N/A | N/A |
| PO4 | 0.99999 | -.048 +<br>1.011 | 0.99985 | -.167 +<br>1.049 | N/A | N/A | N/A | N/A |
| GLU | 0.99998 | -.486 +<br>.998 | 0.99994 | 2.529 +<br>1.02 | N/A | N/A | N/A | N/A |
| BUN | 0.99998 | -.729 +<br>1.016 | 0.99972 | 1.836 +<br>.924 | N/A | N/A | N/A | N/A |
| CRE | 0.99999 | -.066 +<br>1.005 | 0.99997 | -.32 +<br>1.063 | N/A | N/A | N/A | N/A |
| TRIG | 0.99999 | -3.002 +<br>1.004 | N/A | N/A | 0.99997 | 1.58 +<br>1.016 | 0.99997 | 1.58 +<br>1.016 |
| MG | 0.99984 | .022 +<br>.992 | N/A | N/A | 0.99913 | .138 +<br>1.009 | 0.99913 | .138 +<br>1.009 |
| LI | 0.99978 | .074 +<br>.982 | 0.99959 | -.052 +<br>.986 | N/A | N/A | N/A | N/A |
### Linear Regression Statistical Comparison of VALIDATE Chem 1 TABLE 2. Calibration Verification Test Set to the predicate devices.
# TABLE 2: continued
| VALIDATE<br>Chem 1<br>Calibration Verification Test<br>Set | | DOCUMENT<br>Ammonia/<br>Ethanol<br>CAL·VER | | Roche Diagnostics<br>Precitrol Ethyl<br>Alcohol/Ammonia/Lactate<br>Control Low and High | | |
|------------------------------------------------------------|-----------------------------------|-----------------------------------------------------|-----------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------------------------|
| Analyte | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept +<br>slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept +<br>slope(X) | Correlation<br>Coefficient<br>(r) | Regression<br>Equation<br>Y=intercept +<br>slope(X) |
| LAC | 0.99995 | .046 + .979 | N/A | N/A | 0.99990 | -.049 + 1.00 |
| NH3 | 0.99498 | 29.859 + .905 | 0.99945 | 10.778 + .915 | N/A | N/A |
| ETOH | 0.99948 | 2.281 + .965 | 0.99992 | 1.609 + .971 | N/A | N/A |
# Summary:
Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 1 Calibration Verification Test Sei has been shown to be functionally equivalent for calibration and linearity assessment to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER DOCUMENT Iron, Magnesium, Triglyceride CAL.VER, DOCUMENT Ammonia/Ethano CAL. • VER, and Roche Diagnostics Precitrol Ethyl Alcohol/ Ammonia/Lactate Control.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes that resemble a person.
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: K012117 Re: Trade/Device Name: VALIDATE Chem 1 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I, Reserved Product Code: JJY 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 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, ( Sase 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 mionitation on your respons 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 Autman
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: Holall ] | 7 | 2
Device Name: VALIDATE Chem 1 Calibration Verification Test Set
## Indications for Use:
The VALIDATE Chem 1 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: sodium, potassium, chloride, calcium, phosphorus, lactate, glucose, urea nitrogen, creatinine, triglyceride, ammonia, ethanol, magnesium, and lithium.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division o. nical Laboratory Devices
510(k) Number KC12/17
