VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

K033879 · Maine Standards Co. · DKB · Feb 27, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033879
• Device Name: VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
• Applicant: Maine Standards Co.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The VALIDATE TDM Calibration Verification Test Set is used by trained laboratory professions 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, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin

Device Story

VALIDATE TDM Calibration Verification Test Set consists of purified chemicals in human serum matrix; provided in six levels including zero; 5 mL per bottle. Used by laboratory professionals in clinical chemistry systems to verify instrument performance, linearity, and reportable ranges for therapeutic drug monitoring. Device serves as a calibration verification tool; does not perform clinical diagnosis directly. Benefits include ensuring accuracy and reliability of clinical chemistry system results for therapeutic drug monitoring.

Clinical Evidence

No clinical data provided. Bench testing only; traceability established via NIST Standard Reference Materials (SRM 900 and 1599) or primary analytical standards.

Technological Characteristics

Purified chemicals in human serum matrix; liquid, ready-to-use form. 6 levels per set, 5 mL per bottle. Storage at 2-8°C. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by trained laboratory professionals to verify calibration, linearity, and reportable ranges for therapeutic drug monitoring analytes in clinical chemistry systems. No specific patient population or contraindications defined.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• TDM I CAL-VER (K913309)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033879

B. Analyte:
Acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin.

C. Type of Test:
Calibration.

D. Applicant:
Maine Standard Company

E. Proprietary and Established Names:
Validate® TDM Calibration Verification Test Set

F. Regulatory Information:
1. Regulation section:
CFR § 862. 3200, Clinical Toxicology Calibrator, Drug Mixture
2. Classification:
Class II
3. Product Code:
DKB
4. Panel:
Clinical Toxicology (91)

G. Intended Use:
1. Intended Use(s):
Refer to the Indications for Use.
2. Indication(s) for use:
The VALIDATE TDM Calibration Verification Test Set is used by trained laboratory professions 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, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin
3. Special condition for use statement(s):
Prescription Use Only

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4. Special instrument Requirements:
Automated, semi-automated, and manual clinical chemistry systems

H. 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.

I. Substantial Equivalence Information:
1. Predicate device name(s):
TDM I CAL-VER
2. Predicate K number(s):
K913309
3. Comparison with predicate:

| Similarities & Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| 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 on immunochemistry systems and clinical chemistry systems |
| Matrix | Human serum | Human serum |
| Number of levels | 6 including zero | 8 |
| Analytes | Acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin | Acetaminophen, amikacin, carbamazepine, chloramphenicol, disopyramide, ethosuximide, digoxin, gentamicin, lidocaine, phenobarbital, phenytoin, primidone, procainamide, quinidine, theophylline, tobramycin, valproic acid, and vancomycin |

J. Standard/Guidance Document Referenced (if applicable):
N/A

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# K. Test Principle:
N/A

# L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method):
Validate Calibration Verification Test Set Solutions are tested during manufacturing with standards traceable to National Institute for Standard and Technology (NIST) Standard Reference Materials, are available. For analytes where NIST materials are not available, primary analytical standards are used.

NIST SRM 900 and NIST 1599 are utilized for traceability testin for the VALIDATE TDM Calibration Verification Test Set during manufacture. NIST SRM 900, Antiepilepsy Drug Level Assay Standard, contains the therapeutic drugs Phenytoin, Ethosuximide, Phenobarbital, and Primidone at certified values. NIST SRM 1599, Anticonvulsant Drug Level Assay Standard, contains Valproic Acid and Carbamazepine at certified values.

d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

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**M. Conclusion:**

Based upon the information provided, I recommend that the Validate TDM Calibration Verification Test Set be found substantially equivalent with similar defined products based upon 21 CFR § 862.3200, Clinical Toxicology Calibrator, Drug Mixture