LogoFDA 510(k) Search
K Number
K012118
Device Name
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
Manufacturer
MAINE STANDARDS CO.
Date Cleared
2001-08-20

(45 days)

Product Code
JJY
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VALIDATE Chem 2 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: carbon dioxide, uric acid, glucose, and urea nitrogen.
Device Description
VALIDATE Chem 2 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.
More Information

K870252, K893139, K881773

Not Found

No
The document describes a calibration verification test set for chemistry systems, focusing on chemical composition and performance testing against predicate devices. There is no mention of AI or ML in the intended use, device description, or performance studies.

No.
The device is used for verifying calibration, validating reportable ranges, and determining linearity in chemistry systems, not for treating a disease or condition.

No

The device is used to verify calibration, validate reportable ranges, and determine linearity in chemistry systems, not to diagnose diseases or conditions in patients. It assesses the performance of laboratory equipment for specific analytes.

No

The device description clearly states it contains "purified chemicals in an aqueous base" and is provided in "bottles," indicating a physical, chemical-based product, not software.

Yes, 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 specific analytes (carbon dioxide, uric acid, glucose, and urea nitrogen). This is a classic function of an IVD device used in a laboratory setting to ensure the accuracy of diagnostic tests.
  • Device Description: The description details a "Calibration Verification Test Set" containing purified chemicals in an aqueous base, provided in multiple levels. This is consistent with the composition of materials used to calibrate and verify the performance of laboratory instruments that perform in vitro diagnostic tests.
  • Performance Studies: The document describes performance studies comparing the device to predicate devices (which are also IVDs based on their names and K numbers). These studies evaluate the device's performance in the context of laboratory testing.
  • Predicate Devices: The listed predicate devices (DOCUMENT Multi-Analyte CAL-VER, DOCUMENT Uric Acid CAL-VER, DOCUMENT Direct ISE CAL-VER) are clearly calibration and verification materials used in laboratory diagnostics, further supporting the classification of this device as an IVD.

The device is designed to be used in vitro (outside the body) to assess the performance of instruments that perform diagnostic tests on biological samples. This aligns perfectly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

VALIDATE Chem 2 Calibration Verification 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: carbon dioxide, uric acid, glucose and urea nitrogen.

The VALIDATE Chem 2 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: carbon dioxide, uric acid, glucose, and urea nitrogen.

Product codes (comma separated list FDA assigned to the subject device)

JJY

Device Description

VALIDATE Chem 2 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.

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

Not Found

Indicated Patient Age Range

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance of VALIDATE Chem 2 Calibration Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, and DOCUMENT Uric Acid CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 2 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 2 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 analyte was tested in triplicate. The VALIDATE Chem 2 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Multi-Analyte CAL.VER, DOCUMENT Direct ISE CAL.VER, and DOCUMENT Uric Acid CAL.VER.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Correlation Coefficient (r) and Regression Equation (Y=intercept + slope(X)) for GLU, BUN, CO2, and UA when compared to predicate devices.
GLU: 0.99997 (r), 1.493 + .983 (Regression Equation)
BUN: 0.99984 (r), .95 + .965 (Regression Equation)
CO2: 0.99888 (r), .514 + .946 (Regression Equation)
UA: 0.99935 (r), -.192 + 1.009 (Regression Equation)

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.

K870252, K893139, K881773

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.

Not Found

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).

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

AUG 2 0 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: KOIQII I B

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: July 2, 2001

Proprietary Name:VALIDATE Chem 2 Calibration Verification Test Set
Common Name:Calibration Verification
Classification Name:Calibrator, Multi-Analyte

Predicate Devices:

    1. DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by CASCO NERL Diagnostics.
  • DOCUMENT Uric Acid CAL-VER, K893139, manufactured by CASCO 2. NERL Diagnostics.
  • ന് DOCUMENT Direct ISE CAL-VER, K881773, manufactured by CASCO NERL Diagnostics.

Device description: VALIDATE Chem 2 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 2 Calibration Verification 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: carbon dioxide, uric acid, glucose and urea nitrogen.

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

1

Comparison of VALIDATE Chem 2 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 2 Calibration Verrification Test Set with those of the DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, and DOCUMENT Uric Acid CAL•VER.

| | VALIDATE
CHEM 2
Calibration
Verification Test
Set | DOCUMENT
Multi-Analyte
CAL·VER | DOCUMENT
Direct ISE
CAL·VER | DOCUMENT
Uric Acid
CAL·VER |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10002 | M-100 | M-101 | 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. | For in vitro
diagnostic use in
the quantitative
determination of
linearity in
manual,
automated and
semi-automated
chemistry
systems. | For in vitro
diagnostic use in
the quantitative
determination of
linearity in
manual,
automated and
semi-automated
chemistry
systems. |
| Analytes | GLU, BUN, CO2
UA | GLU, BUN, NA,
K, CL, CRE, CA,
PO4 | CO2 | UA |
| Matrix | aqueous | aqueous | aqueous | aqueous |
| Number of
Levels | 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 each level | 15.0 mL each
level | 10.0 mL each
level | 5.0 mL each level |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storane | 2-800 | 18-2590 | 18-2590 | 2-8°C |

TABLE 1.Comparison of VALIDATE Chem 2 Calibration Verification Test Set to
the predicates devices.

2

The performance of VALIDATE Chem 2 Calibration Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Multi-Analyte CAL•VER, DOCUMENT Direct ISE CAL•VER, and DOCUMENT Uric Acid CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 2 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 2 Calibration Verification Test Set and the predicate devices are presented in Table 2.

| | VALIDATE
Chem 2
Calibration
Verification Test Set | | DOCUMENT
Multi-Analyte
CAL·VER | | DOCUMENT
Direct ISE
CAL·VER | | DOCUMENT
Uric Acid
CAL·VER | |
|---------|------------------------------------------------------------|-----------------------------------------------------|--------------------------------------|-----------------------------------------------------|-----------------------------------|-----------------------------------------------------|-----------------------------------|-----------------------------------------------------|
| Analyte | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept

  • slope(X) | Correlation
    Coefficient
    (r) | Regression
    Equation
    Y=intercept
  • slope(X) | Correlation
    Coefficient
    (r) | Regression
    Equation
    Y=intercept
  • slope(X) | Correlation
    Coefficient
    (r) | Regression
    Equation
    Y=intercept
  • slope(X) |
    | GLU | 0.99997 | 1.493 +
    .983 | 0.99994 | 2.529 +
    1.02 | N/A | N/A | N/A | N/A |
    | BUN | 0.99984 | .95 + .965 | 0.99972 | 1.836 +
    .924 | N/A | N/A | N/A | N/A |
    | CO2 | 0.99888 | .514 +
    .946 | N/A | N/A | .99791 | 3.58 +
    .875 | N/A | N/A |
    | UA | 0.99935 | -.192 +
    1.009 | N/A | N/A | N/A | N/A | 0.99990 | .147 +
    .959 |
TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 2
Calibration Verification Test Set to the predicate devices.

Summary:

Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 2 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Multi-Analyte CAL.VER, DOCUMENT Direct ISE CAL.VER, and DOCUMENT Uric Acid 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 is a circular emblem with the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with a curved line beneath them.

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

Re: 510(k) Number: K012118 Trade/Device Name: VALIDATE Chem 2 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 ' 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 Gutman

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

INDICATIONS FOR USE STATEMENT

510(k) Number: _KOI2118

Device Name: VALIDATE Chem 2 Calibration Verification Test Set

Indications for Use:

U

The VALIDATE Chem 2 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: carbon dioxide, uric acid, glucose, and urea nitrogen.

Concurrence of CDRH, Office of Device Evaluation (ODE)

X OR Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Kesia Alexander for Sean Casper
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K012118

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