(45 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a liquid calibration test set for laboratory systems, with no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) product used to verify the calibration, validate reportable ranges, and determine linearity of chemistry systems. It does not directly treat or diagnose patients.
No
The device is a calibration and linearity verification test set used to ensure the accuracy of chemistry systems, not to diagnose medical conditions in patients. It is used by laboratory professionals to verify the proper functioning of diagnostic equipment.
No
The device description clearly states it is a liquid, human serum based calibration verification test set, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "intended for in vitro diagnostic use". It also describes its use in verifying calibration, validating reportable ranges, and determining linearity in chemistry systems, which are all activities performed in a laboratory setting to ensure the accuracy of diagnostic tests.
- Device Description: The description mentions it's a "liquid, human serum based calibration verification test set containing multiple levels". This type of material is used to assess the performance of diagnostic instruments.
- Intended User/Care Setting: It specifies "trained laboratory professionals", indicating its use in a clinical laboratory environment.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The VALIDATE Chem 3 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: total protein, albumin, cholesterol, and iron.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
VALIDATE Chem 3 Calibration Verification Test Set is a liquid, human serum based calibration verification test set containing multiple levels used establish the relationship between theoretical operation and actual performance of each of the included analytes Each set contains one bottle each of six (6) ievels, 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of VALIDATE Chem 3 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Iron / Magnesium / Triglyceride CAL . VER, DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 3 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 3 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 3 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 Total Protein/Albumin/Cholesterol CAL•VER.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r) and Regression Equation (Y=intercept + slope(X)) for each analyte:
TP: Correlation Coefficient (r) = 0.99984, Regression Equation = .109 + .969
ALB: Correlation Coefficient (r) = 0.99920, Regression Equation = .022 + 1.025
CHOL: Correlation Coefficient (r) = 0.99998, Regression Equation = 2.117 + .988
FE: Correlation Coefficient (r) = 0.99950, Regression Equation = -7.942 + .996
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.
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
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: KOI@ II 9
| 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 3 Calibration Verification Test Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Calibrator, Multi-Analyte |
Predicate Devices:
- DOCUMENT Total Protein/Albumin/Cholesterol CAL-VER, K883861, 1. manufactured by CASCO NERL Diagnostics.
-
- DOCUMENT Iron/Magnesium/Triglyceride CAL-VER, K893142, manufactured by CASCO NERL Diagnostics.
Device description: VALIDATE Chem 3 Calibration Verification Test Set is a liquid, human serum based calibration verification test set containing multiple levels used establish the relationship between theoretical operation and actual performance of each of the included analytes Each set contains one bottle each of six (6) ievels, including zero. Each bottle contains 5 milliliters.
Intended use: VALIDATE Chem 3 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: total protein, albumin, cholesterol and iron.
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 3 Calibration Verification Test Set to the predicate devices:
Table 1 compares characteristics of the VALIDATE Chem 3 Calibration Verification Test Set with those of the DOCUMENT Iron / Magnesium / Triglyceride CAL�VER, DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER.
| | VALIDATE CHEM 3
Calibration
Verification Test Set | DOCUMENT Total
Protein / Albumin /
Cholesterol CAL•VER | DOCUMENT
Iron, Magnesium,
Triglyceride
CAL•VER |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog # | 10003 | M-102 | M-103 |
| 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. |
| Analytes | TP, ALB, CHOL, FE | TP, ALB, CHOL | FE |
| Matrix | protein | protein | aqueous |
| Number of
Levels | 6 including Zero | 5 | 5 |
| Preparation | Liquid,
ready to use | Liquid,
ready to use | Liquid,
ready to use |
| Packaging | 5.0 mL each level | 8.0 mL each level | 10.0 mL each level |
| Stability | Until Expiration | Until Expiration | Until Expiration |
| Storage | 2-8°C | 2-8°C | 2-8°C |
Comparison of Products TABLE 1.
The performance of VALIDATE Chem 3 Calibration Verification Test Set solutions on the Roche Diagnostics Hitachi 911 instrument system as compared to DOCUMENT Iron / Magnesium / Triglyceride CAL . VER, DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER has been shown to be substantially equivalent using pre-production lots of VALIDATE Chem 3 Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE Chem 3 Calibration Verification Test Set and the predicate devices are presented in Table 2.
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TABLE 2. Linear Regression Statistical Comparison of VALIDATE Chem 3 Calibration Verification Test Set to the predicate devices.
| | VALIDATE
Chem 3
Calibration Verification
Test Set | | DOCUMENT
Total Protein / Albumin /
Cholesterol
CAL·VER | | 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) | Correlation
Coefficient
(r) | Regression
Equation
Y=intercept +
slope(X) |
| TP | 0.99984 | .109 + .969 | 0.99997 | .125 + .982 | N/A | N/A |
| ALB | 0.99920 | .022 + 1.025 | 0.99856 | .502 + .874 | N/A | N/A |
| CHOL | 0.99998 | 2.117 + .988 | 0.99997 | -3.359 + 1.016 | N/A | N/A |
| FE | 0.99950 | -7.942 + .996 | N/A | N/A | 0.99992 | -3.464 + 1.021 |
Summary:
ਨੇ
Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE Chem 3 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 Total Protein/Albumin/Cholesterol 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 consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 0 2001
Ms. Christine V. Beach Manager, RA/QA Maine Standards Company, LLC 765 Roosevelt Trail Windham, ME 04062
Re: 510(k) Number: K012119 Trade/Device Name: VALIDATE Chem 3 Calibration Verification Test Set Regulation Number: 862.1660 Regulatory Class: Class I 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, 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 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: Kola119
Device Name: VALIDATE Chem 3 Calibration Verification Test Set
Indications for Use:
The VALIDATE Chem 3 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: total protein, albumin, cholesterol, and iron.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) X OR Over-The-Counter Use
Kesia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K012119