(46 days)
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No
The 510(k) summary describes a calibration verification test set, which is a reagent used to assess the performance of chemistry analyzers. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on linear regression analysis of recovered values, which is a standard statistical method, not AI/ML.
No
The device is an in vitro diagnostic product used for calibrating and verifying other chemistry systems, not for directly treating patients.
No
The device is a calibration verification test set, used to verify the calibration and linearity of laboratory chemistry systems. It is not used to diagnose a patient condition directly, but rather to ensure the accuracy of the diagnostic equipment.
No
The device description clearly states that the device is a "Test Set" containing "purified chemicals in a protein matrix" in bottles. This indicates a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The VALIDATE Chem 9 Calibration Verification Test Set is intended for in vitro diagnostic use..." This is the most direct indicator.
- Purpose: The device is used to verify the calibration and linearity of automated and manual chemistry systems. These systems are used to perform diagnostic tests on patient samples (in vitro). The calibration and verification of these systems are crucial for ensuring the accuracy of the diagnostic results.
- Analytes: The device is used to assess the performance of tests for a wide range of analytes commonly measured in clinical chemistry for diagnostic purposes (e.g., glucose, cholesterol, creatinine, electrolytes).
- Intended User: The intended users are "trained laboratory professionals," who are the individuals who perform in vitro diagnostic testing in a laboratory setting.
All of these factors align with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VALIDATE Chem 9 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following eighteen analytes: albumin (ALB), calcium (CA), cholesterol (CHOL), chloride (CL), carbon dioxide (CO2), creatinine (CRE), glucose (GLU), iron (FE), lactate (LAC), lithium (LI), magnesium (MG), phosphorus (PQ4), potassium (K), sodium (NA), total protein (TP), triglyceride (TRIG), urea nitrogen (BUN), and uric acid (UA).
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
VALIDATE Chem 9 Calibration Verification Test Set contains purified chemicals in a protein matrix. 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 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
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Indicated Patient Age Range
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Intended User / Care Setting
trained laboratory professionals, clinical chemistry systems
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)
Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 9 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Serum Multi-Analyte CAL.VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r), Regression Equation Y = slope(X) + intercept
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 word "maine" is on the top left, and the word "standards" is on the bottom right. A diagonal line separates the two words, and the words "COMPANY LLC" are below the word "standards".
1023352
NOV 22 2002
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: _
Maine Standards Company Submitter: Address: 765 Roosevelt Trail Windham, ME 04062 207-892-1300 Telephone: Fax: 207-892-2266 Christine Beach, Mgr. RA/QA Contact:
Summary prepared on: September 30, 2002
| Proprietary Name: | VALIDATE Chem 9 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Devices:
-
- DOCUMENT Serum Multi-Analyte CAL-VER, K950469, manufactured by CASCO NERL Diagnostics.
-
- Ortho-Clinical Diagnostics VITROS Calibrator Kit 1
Device description: VALIDATE Chem 9 Calibration Verification Test Set contains purified chemicals in a protein matrix. 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 5 milliliters.
Intended use: VALIDATE Chem 9 Calibration Verification Test Set is intended for in vitro diagnostic use for quantitatively verifying calibration, validating reportable ranges, and determining linearity for automated and manual chemistry systems for the following eighteen analytes: albumin (ALB), calcium (CA), cholesterol (CHOL), chloride (CL), carbon dioxide (CO2), creatinine (CRE), glucose (GLU), iron (FE), lactate (LAC), lithium (LI), magnesium (MG), phosphorus (PQ4), potassium (K), sodium (NA), total protein (TP), triglyceride (TRIG), urea nitrogen (BUN), and uric acid (UA).
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Comparison of VALIDATE Chem 9 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 9 Calibration Verification Test Set with those of the DOCUMENT Serum Multi-Analyte CAL.•VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1.
| | VALIDATE CHEM 9
Calibration
Verification Test Set | DOCUMENT Serum
Multi-Analyte
CAL·VER | Ortho-Clinical
Diagnostics VITROS
Calibrator Kit 1 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Catalog # | 109 | M-115 | 1882208 |
| 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 use in the
calibration of VITROS
chemistry systems for
the quantitative
measurement
of lactate. |
| Analytes | ALB, CA, CHOL, CL,
CO2, CREAT, GLU, FE,
LAC, LITH, MG, PO4,
K, NA, TPROT, TRIG,
BUN, URIC ACID | ALB, CA, CHOL, CL,
CO2, CREAT, GLU, FE,
LITH, MG, PO4, K, NA,
TPROT, TRIG, BUN,
URIC ACID | LAC |
| Matrix | Bovine serum albumin | Human serum | Bovine serum albumin |
| Number of
Levels | 5 | 5 | 3 |
| Preparation | Liquid,
ready to use | Liquid,
ready to use | Lypholized |
| Packaging | 5.0 mL each level | 2 x 3.0 mL each level | 3.0 mL each level |
| Stability | 9 months | 9 months | 24 hours after
reconstitution |
| Storage | -10 to -20°C | -10 to -20°C | -10 to -20°C |
Comparison of Products TABLE 1.
The performance of VALIDATE Chem 9 Calibration Verification Test Set solutions on the VITROS instrument system as compared to DOCUMENT Serum Multi-Analyte CAL.•VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1 been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 9 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 9 Calibration Verification Test Set and the predicate devices are presented in Table 2.
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| VALIDATE | DOCUMENT | |||
|---|---|---|---|---|
| Chem 9 Calibration Verification Test Set | Serum Multi-Analyte CAL•VER | |||
| Analyte | Correlation Coefficient | |||
| (r) | Regression Equation | |||
| Y = slope(X) + intercept | Correlation Coefficient | |||
| (r) | Regression Equation | |||
| Y = slope(X) + intercept | ||||
| ALB | 0.9942 | x - 0.1 | 0.998 | 0.997x + 0.022 |
| BUN | 0.9999 | 1.0138x - 0.4276 | 0.999 | 1.005x + 0.618 |
| CA | 0.9974 | 1.01x + 0.288 | 0.999 | 0.995x + 0.035 |
| CHOL | 0.9999 | 0.9935x + 1.8102 | 0.995 | 1.058x - 6.192 |
| CL | 0.9996 | 0.9581x + 3.6226 | 0.998 | 1.010x - 1.389 |
| CO2 | 0.9971 | 0.875x + 1.675 | 0.998 | 1.009x - 0.176 |
| CRE | 0.9986 | 0.9364 + 0.1791 | 0.999 | 0.974x + 0.073 |
| FE | 0.9988 | 0.9205x + 14.617 | 0.998 | 1.119x - 14.492 |
| GLU | 0.9999 | 1.0132x - 0.7707 | 0.999 | 1.050x - 9.370 |
| K | 0.9987 | 0.9984x - 0.2576 | 0.999 | 0.983 + 0.170 |
| LITH | 0.9997 | 0.9733x + 0.0187 | 0.994 | 0.924x + 0.015 |
| MG | 0.9993 | 0.9832 + 0.1053 | 0.998 | 1.051x - 0.082 |
| NA | 0.9991 | 1.0042x + 1.8979 | 0.998 | 1.076x - 7.561 |
| PO4 | 0.9998 | 0.975x + 0.035 | 0.999 | 0.992x + 0.093 |
| TP | 0.9986 | 1.097x - 0.5097 | 0.998 | 1.086x - 0.261 |
| TRIG | 0.9999 | 1.0226x - 3.6259 | 0.999 | 1.018x + 2.292 |
| URIC | ||||
| ACID | 0.9997 | 0.97x + 0.161 | 0.999 | 0.992x + 0.040 |
| TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 9 | ||||
|---|---|---|---|---|
| Calibration Verification Test Set to the predicate devices. |
| VALIDATE
Chem 9
Calibration Verification Test Set | | | Ortho-Clinical Diagnostics VITROS
Calibrator Kit 1 | | |
|---------------------------------------------------------|--------------------------------|-------------------------------------------------|-------------------------------------------------------|-------------------------------------------------|--|
| Analyte | Correlation Coefficient
(r) | Regression Equation
Y = slope(X) + intercept | Correlation Coefficient
(r) | Regression Equation
Y = slope(X) + intercept | |
| LAC | 1.0000 | 1.012x - 0.0272 | 0.9995 | 0.9398x + 0.0692 | |
Summary:
Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 9 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Serum Multi-Analyte CAL.�VER and Ortho-Clinical Diagnostics VITROS Calibrator Kit 1.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized image of three birds in flight, one behind the other. The birds are black and have a simple, abstract design.
od and Drug Administra 98 Gaither Road ckville MD 20850
OV 22 2002
Ms. Christine Beach Manager, RA/QA Maine Standards Company 765 Roosevelt Trail - Suite 9A Windham, ME .04062
Re: K023352
Trade/Device Name: Validate Chem 9 Calibration Verification Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 30, 2002 Received: October 7, 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. Iisting 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number: ________________
Device Name: Validate Chem 9 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 9 Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following eighteen analytes. albumin, calcium, cholesterol, chloride, carbon dioxide, creatinine, glucose, iron, lactate, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglyceride, urea nitrogen, and uric acid.
Gran Crogn
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023352
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use