VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007

• K Number: K013265
• Device Name: VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
• Manufacturer: MAINE STANDARDS CO.
• Date Cleared: 2001-11-20 ( 50 days)
• Product Code: JJY
• Regulation Number: 862.1660

Intended Use

The VALIDATE Chem 7 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 analytes: iron, creatinine, ammonia, and ethanol.

Device Description

VALIDATE Chem 7 Calibration Verification Test Set is an aqueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Predicate Devices

K893142, K870252, K962629

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a calibration verification test set for chemistry systems, which is a standard laboratory control material. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis relies on linear regression, a statistical method, not AI/ML.

Therapeutic

No
This device is for in vitro diagnostic use, intended to verify calibration, validate reportable ranges, and determine linearity in chemistry systems for specific analytes; it does not directly treat or diagnose patients.

Diagnostic

No

This device is intended for in vitro diagnostic use to verify calibration and determine linearity in chemistry systems, not to diagnose a patient's medical condition. It's used to assess the performance of diagnostic equipment, not directly diagnose a disease or condition in a human.

SaMD (Software as a Medical Device)

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.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "intended for in vitro diagnostic use".
• Function: The device is used to verify calibration, validate reportable ranges, and determine linearity in chemistry systems, which are all activities performed in a laboratory setting to ensure the accuracy of diagnostic tests.
• Analytes: It tests for specific analytes (iron, creatinine, ammonia, and ethanol) that are measured in biological samples for diagnostic purposes.
• Device Description: It is described as a "calibration verification test set" used to assess the performance of chemistry systems.
• Intended User: The intended users are "trained laboratory professionals," indicating it is used in a clinical laboratory environment.

All these points strongly support the classification of this device as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

VALIDATE Chem 7 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 analytes: iron, creatinine, ammonia, and ethanol.

Product codes

JJY

Device Description

VALIDATE Chem 7 Calibration Verification Test Set is an aqueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each set contains one bottle each of six (6) levels, including zero. Each bottle contains 5 milliliters.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems

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

Not Found

Summary of Performance Studies

Linear regression analysis was carried out on recovered values for iron, creatinine, ammonia, and ethanol. The analytes were tested in triplicate. The VALIDATE Chem 7 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL.•VER, DOCUMENT Multi-Analyte CAL•VER, and DOCUMENT Ammonia/Ethanol CAL•VER.

Key Metrics

Correlation Coefficient (r) and Regression Equation (Y = intercept + slope(X)) for analytes:
FE: 0.99997, .327 + 1.001X
CRE: 0.99952, .091 + .983X
NH3: 0.99994, -.363 + 1.019X
ETOH: 0.99998, -.159 + 1.009X

Predicate Device(s)

K893142, K870252, K962629

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company LLC. The logo is divided by a diagonal line, with "maine" on the top left and "standards" on the bottom right. The text "NOV 20 2001" is also visible on the right side of the image.

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:

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 27, 2001

Proprietary Name:	VALIDATE Chem 7 Calibration Verification Test Set
Common Name:	Calibration Verification
Classification Name:	Calibrator, Multi-Analyte

Predicate Devices:

• DOCUMENT Iron/Magnesium/Triglyceride 1. CAL-VER. K893142. manufactured by CASCO NERL Diagnostics.
• 2. DOCUMENT Multi-Analyte CAL-VER, K870252, manufactured by CASCO-NERL Diagnostics.
• DOCUMENT Ammonia/Ethanol CAL-VER, K962629, manufactured by 3. CASCO-NERL Diagnostics.

Device description: VALIDATE Chem 7 Calibration Verification Test Set is an aqueous based calibration verification test set containing multiple levels used to establish the relationship between theoretical operation and actual performance 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 7 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 analytes: iron, creatinine, ammonia, and ethanol.

7 6 5 R O O S E V E L T T A I L . W I N D H A M , M A I N E 0 4 0 6 2 TEL:[phone] · FAX:[phone] · TOLL-FREE:800.377.968 www.mainestandards.com

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Comparison of VALIDATE Chem 7 Calibration Verification Test Set to the predicate devices:

Table 1 compares characteristics of the VALIDATE Chem 7 Calibration Verification Test Set with those of the DOCUMENT Iron/Magnesium/Triglyceride CAL�VER, Multi-Analyte CAL.VER, and DOCUMENT Ammonia/Ethanol DOCUMENT CAL·VER.

| | VALIDATE
CHEM 7
Calibration
Verification
Test Set | DOCUMENT
Iron,
Magnesium,
Triglyceride
CAL•VER | DOCUMENT
Multi-Analyte
CAL•VER | DOCUMENT
Ammonia /
Ethanol
CAL•VER |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10007 | M-103 | M-100 | M-108 |
| 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 | FE, CRE, NH3,
ETOH | FE, MG, TRIG | GLU, BUN, NA,
K, CL, CRE, CA,
PO4 | NH3, ETOH |
| 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 | 10.0 mL each
level | 15 mL each level | 3.0 mL each
level |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C | 18-25°C | 2-8°C |

TABLE 1.	Comparison of Products
----------	------------------------

The performance of VALIDATE Chem 7 Calibration Verification Test Set solutions Beckman CX instrument system as compared to DOCUMENT on the Iron/Magnesium/Triglyceride CAL•VER, DOCUMENT Multi-Analyte CAL•VER, and DOCUMENT Ammonia/Ethanol CAL.•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 7 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 7 Calibration Verification Test Set and the predicate device are presented in Table 2.

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• TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 7 Calibration Verification Test Set to the predicate devices.

| VALIDATE
Chem 7
Calibration Verification Test Set | | | DOCUMENT
Iron, Magnesium, Triglyceride
CAL•VER | |
|---------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------|------------------------------------------------------|-------------------------------------------------|
| Analyte | Correlation
Coefficient (r) | Regression Equation
Y = intercept + slope(X) | Correlation
Coefficient
(r) | Regression Equation
Y = intercept + slope(X) |
| FE | 0.99997 | .327 + 1.001X | 0.99979 | -5.539 + 1.007X |
| | VALIDATE
Chem 7
Calibration Verification Test Set | | DOCUMENT
Multi-Analyte
CAL•VER | |
| Analyte | Correlation
Coefficient (r) | Regression Equation
Y = intercept + slope(X) | Correlation
Coefficient (r) | Regression Equation
Y = intercept + slope(X) |
| CRE | 0.99952 | .091 + .983X | 0.99987 | -.099 + 1.007X |

| | VALIDATE
Chem 7
Calibration Verification Test Set | | DOCUMENT
Ammonia/Ethanol
CAL·VER | |
|---------|---------------------------------------------------------|-------------------------------------------------|----------------------------------------|-------------------------------------------------|
| Analyte | Correlation
Coefficient (r) | Regression Equation
Y = intercept + slope(X) | Correlation
Coefficient
(r) | Regression Equation
Y = intercept + slope(X) |
| NH3 | 0.99994 | -.363 + 1.019X | 0.99809 | -11.616 + 1.074X |
| ETOH | 0.99998 | -.159 + 1.009X | 0.99872 | -1.261 + 1.04X |

Summary:

Linear regression analysis was carried out on recovered values for iron, creatinine, ammonia, and ethanol. The analytes were tested in triplicate. The VALIDATE Chem 7 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Iron/Magnesium/Triglyceride CAL.•VER, DOCUMENT Multi-Analyte CAL•VER, and DOCUMENT Ammonia/Ethanol CAL•VER.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Christine Beach Manager RA/QA Maine Standards Company 765 Roosevelt Trail Windham, ME 04062

NOV 2 0 2001

K013265 Re:

R013205
Trade/Device Name: VALIDATE Chem 7 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: September 27, 2001 Received: October 1, 2001

Dear Ms. Beach:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your 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 for use sualed in the encreating of the enactment date of the Medical Device Amendments, or to conimores prior to ria) 20, 20, 20, 20, 2017 11:25 provisions of the Federal Food, Drug, de nees that have been route approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , there core, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or babyer to oach as out 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 r loase of actived that i Drivination that your device complies with other requirements of the Act that I Dri has made a avad regulations administered by other Federal agencies. You must or any I 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 Of It in the quality systems (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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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 nredicate 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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NOV 2 0 2001

INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: VALIDATE Chem 7 Calibration Verification Test Set

Indications for Use:

The VALIDATE Chem 7 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; iron, creatinine, ammonia, 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 and ethanol. STIN

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013265

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use