(74 days)
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No
The device is a calibration verification test set, a chemical reagent used to assess the performance of clinical chemistry systems. The description focuses on the chemical composition and intended use for linearity and calibration verification, with no mention of AI or ML.
No
This device is a calibration verification test set used by laboratory professionals to quantitatively determine linearity and verify calibration and reportable range in clinical chemistry systems. It is not used for treating or diagnosing any medical condition in directly in patients.
No
This device is used for calibration verification and linearity assessment of clinical chemistry systems, not for diagnosing a medical condition in a patient. It helps ensure the accuracy of other diagnostic devices.
No
The device description explicitly states that the device "contains purified chemicals in a human serum matrix" 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 explicitly states it's for "quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems". These systems are used to perform tests on biological samples (like the human serum matrix mentioned in the device description) to obtain information about a patient's health.
- Device Description: The device contains "purified chemicals in a human serum matrix". This indicates it's a reagent or control material used in an in vitro test.
- Intended User: The intended user is "trained laboratory professionals", which is typical for IVD devices used in a laboratory setting.
- Performance Studies: The performance studies describe testing and analysis of the device's performance in a laboratory setting, using metrics like correlation coefficient and regression analysis, which are relevant to the accuracy and reliability of an IVD.
- Predicate Device: The mention of predicate devices (K913309, DOCUMENT TDM CAL-VER) which are also likely IVDs, further supports the classification of this device as an IVD.
In summary, the device is designed to be used in a laboratory setting to verify the performance of clinical chemistry systems that perform in vitro diagnostic tests on human samples. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"VALIDATE TDM 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 seventeen analytes: acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, tobramycin, valproic acid, and vancomycin."
Product codes (comma separated list FDA assigned to the subject device)
DKB
Device Description
"VALIDATE TDM Calibration Verification Test Set contains purified chemicals in a human serum 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 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
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Indicated Patient Age Range
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Intended User / Care Setting
"The VALIDATE TDM 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 analytes: acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin."
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 TDM Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT TDM I CAL•VER and human serum spiked with salicylate."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (r) and Regression Equation (Y = slope(X) + intercept) for various analytes (ACET, AMI, CARB, DIG, GENT, LIDO, NAPA, PHENO, PHENY, PRIM, PROC, QUIN, THEO, TOB, VPA, VANC, SALI).
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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§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is 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, with a line going through it. The word "standards" is on the bottom right, and the words "COMPANY LLC" are below it in smaller letters.
FEB 2 7 2004
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: _ 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. |
| Analytes | acetaminophen, amikacin,
carbamazepine, digoxin, gentamicin,
lidocaine, N-acetylprocainamide,
phenobarbital, phenytoin, primidone,
procainamide, quinidine, salicylate,
theophylline, tobramycin, valproic acid,
and vancomycin | acetaminophen, amikacin,
carbamazepine, chloramphenicol,
disopyramide, ethosuximide, digoxin,
gentamicin, lidocaine,
N-acetylprocainamide, phenobarbital,
phenytoin, primidone, procainamide,
quinidine, theophylline, tobramycin,
valproic acid, and vancomycin |
| Matrix | human serum | human serum |
| Number of
Levels | 6 | 8 |
| Preparation | Liquid, ready to use | Liquid, ready to use |
| Packaging | 5.0 mL each level | 5.0 mL each level |
| Stability | Until expiration | Until expiration |
| Storage | 2 to 8°C | 2 to 8°C |
TABLE 1. Comparison of Products
The performance of VALIDATE TDM Calibration Test Set solutions on the VITROS instrument system as compared to DOCUMENT TDM I CAL.aVER and human serum spiked with salicylate has been shown to be substantially equivalent using preproduction lots of VALIDATE TDM Calibration Verification Test Set. The results of correlation comparisons between the VALIDATE TDM Calibration Test Set and the predicate devices are presented in Table 2.
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| | VALIDATE®
TDM | | DOCUMENT®
TDM I
CAL·VER | |
|---------|-----------------------------------|-------------------------------------------------|--------------------------------|-------------------------------------------------|
| | Calibration Verification Test Set | | | |
| Analyte | Correlation Coefficient
(r) | Regression Equation
Y = slope(X) + intercept | Correlation Coefficient
(r) | Regression Equation
Y = slope(X) + intercept |
| ACET | 0.9981 | 0.936x + 2.65 | 0.9974 | 0.8718x + 10.14 |
| AMI | 0.9940 | 1.099x - 0.79 | 0.9971 | 1.0469x - 0.4331 |
| CARB | 0.9989 | 1.009x - 0.01 | 0.9973 | 1.04x + 0.15 |
| DIG | 0.9976 | 1.026x - 0.01 | 0.9979 | 1.015x - 0.02 |
| GENT | 0.9968 | 0.898x + 0.19 | 0.9939 | 0.8639x + 0.26 |
| LIDO | 0.9987 | 1.025x - 0.07 | 0.997 | 1.0727x - 0.1567 |
| NAPA | 0.9975 | 0.995x + 0.01 | 0.9971 | 1.0363x - 0.42 |
| PHENO | 0.9981 | 0.999x - 0.22 | 0.9974 | 0.9919x + 0.39 |
| PHENY | 0.9986 | 0.972x + 0.34 | 0.999 | 1.0025x + 0.10 |
| PRIM | 0.9994 | 1.036x - 0.18 | 0.9993 | 0.9831x - 0.0014 |
| PROC | 0.9971 | 1.015x - 0.06 | 0.9965 | 1.1413x - 1.0 |
| QUIN | 0.9994 | 1.043x - 0.05 | 0.9981 | 1.0541x - 0.08 |
| THEO | 0.9994 | 0.981x + 0.17 | 0.9992 | 0.9933x - 0.11 |
| TOB | 0.9985 | 1.077x - 0.16 | 0.9935 | 0.9278x + 0.38 |
| VPA | 0.999 | 1.037x - 1.17 | 0.9983 | 1.0231x - 0.65 |
| VANC | 0.9995 | 1.018x - 0.3 | 0.992 | 0.9688x + 0.12 |
| TABLE 2. Linear Regression Statistical Comparison of VALIDATE TDM | ||||
|---|---|---|---|---|
| Calibration Verification Test Set to the predicate devices. |
| VALIDATE
TDM
| Calibration Verification Test Set | Spiked Human Serum | |||
|---|---|---|---|---|
| Analyte | Correlation Coefficient | |||
| (r) | Regression Equation | |||
| Y = slope(X) + intercept | Correlation Coefficient | |||
| (r) | Regression Equation | |||
| Y = slope(X) + intercept | ||||
| SALI | 0.9985 | $0.958x + 7.21$ | 0.9916 | $0.902x + 17.99$ |
Summary:
Linear regression analysis was carried out on recovered values for each analyte. Each analyte was tested in triplicate. The VALIDATE TDM Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT TDM I CAL•VER and human serum spiked with salicylate.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 27 2004
Ms. Christine V. Beach Manager, QA/RA Maine Standards Co. 765 Roosevelt Trail Suite 9A Windham, ME 04062
Re: K033879
Trade/Device Name: Validate® TDM Calibration Verification Test Set Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: December 11, 2003 Received: December 16, 2003
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, 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 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 (OS) 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). You may obtain other general information on your responsibilities under the Act 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.
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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: K033871
Device Name: Validate® TDM Calibration Verification Test Set
Indications for Use:
The VALIDATE TDM 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 analytes: acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
5704k K033879