(45 days)
Not Found
No
The device is a calibration verification test set, a chemical reagent used to assess the performance of laboratory instruments. There is no mention of AI or ML in the description, intended use, or performance studies.
No.
The device is used for verifying calibration and determining linearity of chemistry systems, which are quality control measurements for laboratory instruments, not for treating patients.
No
This device is described as a "Calibration Verification Test Set" used for "verifying calibration, validating reportable ranges, and determining linearity of automated, semi-automated and manual chemistry systems." It is used to assess the performance of laboratory equipment, not to diagnose a medical condition in a patient.
No
The device description clearly states it contains purified enzymes in a solution and is provided in bottles, indicating it is a physical reagent kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used by trained laboratory professionals for "quantitatively verifying calibration, validating reportable ranges, and determining linearity of automated, semi-automated and manual chemistry systems for the following analytes..." This describes a process performed in vitro (outside the living body) on samples to assess the performance of laboratory instruments used for diagnostic testing.
- Device Description: The description mentions "purified enzymes in a solution" and "Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes." This further supports the idea that the device is a reagent or control used in laboratory testing.
- Performance Studies: The performance studies compare the device to other "Calibration Verification Test Sets" and "Linearity Test Sets," which are typical categories of IVD devices used for quality control and validation in clinical laboratories.
- Predicate Devices: The listed predicate devices (DOCUMENT Enzyme Linearity Test Set, DOCUMENT Total/Direct Bilirubin Test Set, and Lipase LIN-TROL) are also IVD devices used for similar purposes.
Based on the provided information, the VALIDATE Chem 4 Calibration Verification Test Set fits the definition of an In Vitro Diagnostic device. It is a reagent or control material used in a laboratory setting to assess the performance of instruments used for diagnostic testing.
N/A
Intended Use / Indications for Use
The VALIDATE Chem 4 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: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin, and direct bilirubin.
The VALIDATE Chem 4 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity of automated, semi-automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin and direct bilirubin.
Product codes
JJY
Device Description
VALIDATE Chem 4 Calibration Verification Test Set contains purified enzymes in a solution of bovine albumin stabilized with ethylene glycol. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains 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
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
Not Found
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 and the VALIDATE Chem 4 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Enzyme Linearity Test Set, DOCUMENT Total/Direct Billrubin Test Set, and Sigma Diagnostics Lipase LIN-TROL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r) and Regression Equation (Y=intercept + slope(X)) were reported for various analytes (ALT, AST, GGT, CK, LD, ALP, AMY, LIP, T. BILI, D.BILI) when comparing VALIDATE Chem 4 Calibration Verification Test Set to predicate devices. For example, for ALT, the correlation coefficient was 0.999945 and the regression equation was 6.121 + 0.928.
Predicate Device(s)
Reference Device(s)
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.
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MAINE STANDARDS COMPANY, LLC
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: Holalao .."
| 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 4 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Devices:
- DOCUMENT Enzyme Linearity Test Set, K932458, manufactured by 1. CASCO NERL Diagnostics.
- DOCUMENT Total/Direct Bilirubin Test Set, K924493, manufactured by 2. CASCO NERL Diagnostics.
- Lipase LIN-TROL, K863751, manufactured by Sigma Diagnostics, Inc. ന്
Device description: VALIDATE Chem 4 Calibration Verification Test Set contains purified enzymes in a solution of bovine albumin stabilized with ethylene glycol. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains six (6) levels, including zero. Each bottle contains 5 milliliters.
Intended use: VALIDATE Chem 4 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: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin, and direct bilirubin.
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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Ko 12120
Comparison to Predicate Devices:
| VALIDATE | DOCUMENT | DOCUMENT | Sigma | |
|---|---|---|---|---|
| CHEM 4 | Enzyme | Total/Direct | Lipase Lin-Trol | |
| Calibration | Linearity Test | Bilirubin | ||
| Test Set | ||||
| Verification Test | ||||
| Set | Set | |||
| Catalog # | 10004 | E-100 | M-107 | L 1401 |
| For in vitro | For in vitro | For in vitro | For estimating the | |
| diagnostic use in | diagnostic use in | limits of linearity | ||
| the quantitative | the quantitative | and/or calibration | ||
| determination of | determination of | verification of | ||
| linearity in | linearity in | reagent/ | ||
| manual, | manual, | instrument | ||
| automated and | automated and | systems. | ||
| Intended Use | semi-automated | semi-automated | ||
| ranges, and | chemistry | chemistry | ||
| determining | systems. | systems. | ||
| linearity in | ||||
| automated, semi- | ||||
| automated and | ||||
| manual chemistry | ||||
| systems. | ||||
| ALT, AST, CK, | ||||
| LD, ALP, AMY, | ALT, AST, CK, | Total Bilirubin | Lipase | |
| Analytes | LIP, GGT, Total | LD, ALP, AMY, | Direct Bilirubin | |
| Bilirubin, and | GGT | |||
| Direct Bilirubin | ||||
| Bovine Serum | Bovine Serum | Human Serum | ||
| Matrix | Albumin | Albumin | Human Serum | Base with Porcine |
| Lipase | ||||
| stabilized with | stabilized with | Albumin | ||
| Ethylene Glycol | Ethylene Glycol | |||
| Number of | 1 Preparation | |||
| Levels | 6 including Zero | 8 including Zero | 5 | with various |
| dilutions | ||||
| Preparation | Liquid, | Liquid, | Liquid, | |
| ready to use | ready to use | ready to use | Lyophilized | |
| 3 mL freeze dried | ||||
| Packaging | 5.0 mL each level | 5.0 mL each level | 4.0 mL each level | concentrate |
| Stability | Until Expiration | Until Expiration | Until Expiration | Until Expiration |
| Storage | -10 to -20° C. | -10 to -20° C. | -10 to -20° C. | 2- 4° C. |
The performance of VALIDATE Chem 4 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Enzyme Linearity Test Set, DOCUMENT Total/Direct Bilirubin Test Set, and Sigma Diagnostics Lipase LIN-TROL has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 4 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 4 Calibration Verification Test Set and the predicate devices are presented in Table 2.
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| Table 2. | Linear Regression Statistical Comparison between VALIDATE Chem 4
Calibration Verification Test Set and the predicate devices. |
| ---------- | ---------------------------------------------------------------------------------------------------------------------------------- |
|---|
| | VALIDATE Chem 4
Calibration
Verification Test Set | | DOCUMENT
Enzyme Linearity
Test Set | | DOCUMENT
Total/Direct Bilirubin
Test Set | | Sigma Diagnostics
Lipase LIN-TROL | |
|---------|---------------------------------------------------------|-----------------------------------------------------|------------------------------------------|-----------------------------------------------------|------------------------------------------------|-----------------------------------------------------|--------------------------------------|-----------------------------------------------------|
| 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) |
| ALT | 0.999945 | 6.121 +
.928 | 1.00000 | -.141 +
.996 | N/A | N/A | N/A | N/A |
| AST | 0.99964 | 4.351 +
.949 | 0.99992 | -4.055 +
1.022 | N/A | N/A | N/A | N/A |
| GGT | 0.99995 | -.026 +
.989 | 0.99997 | -2.83 +
1.006 | N/A | N/A | N/A | N/A |
| CK | 0.99113 | -8.94 +
.937 | 0.99992 | 10.354 +
.951 | N/A | N/A | N/A | N/A |
| LD | 0.99971 | 8.228 +
.953 | 0.99988 | 3.402 +
.954 | N/A | N/A | N/A | N/A |
| ALP | 0.99999 | -1.285 +
1.001 | 0.99999 | -.59 +
1.001 | N/A | N/A | N/A | N/A |
| AMY | 0.99998 | -3.311 +
1.003 | 0.99979 | 27.07 +
.945 | N/A | N/A | N/A | N/A |
| LIP | 0.99879 | -1.399 +
.965 | N/A | N/A | N/A | N/A | 0.99935 | 6.885 +
1.001 |
| T. BILI | 0.99956 | .236 +
.952 | N/A | N/A | 1.00000 | .02 +.99X | N/A | N/A |
| D.BILI | 0.99627 | .477 +.86 | N/A | N/A | 0.99999 | .027 +
1.018 | N/A | N/A |
Summary:
Linear regression analysis was carried out on recovered values for each analyte and the VALIDATE Chem 4 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Enzyme Linearity Test Set, DOCUMENT Total/Direct Billrubin Test Set, and Sigma Diagnostics Lipase LIN-TROL.
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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: K012120 Re: Trade/Device Name: VALIDATE Chem 4 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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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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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: Kolalao
Device Name: VALIDATE Chem 4 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 4 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity of automated, semi-automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin and direct bilirubin .
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Kesia Alexander Inchan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012120
OR
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