PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS

K033246 · Roche Diagnostics Corp. · DLJ · Dec 2, 2003 · Clinical Toxicology

Device Facts

• Record ID: K033246
• Device Name: PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
• Applicant: Roche Diagnostics Corp.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Dec 2, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The Preciset DAT THC calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers. The Preciset DAT THC 20 calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.

Device Story

Preciset DAT THC and THC 20 calibrators consist of multi-level solutions of Δ9-THC-COOH in drug-free human urine with preservative. Used in clinical laboratory settings to calibrate automated chemistry analyzers for cannabinoid detection. Calibrator levels are verified via GC/MS. Provides reference points for assay quantification; ensures accuracy of patient urine drug testing results.

Clinical Evidence

No clinical data. Bench testing only; traceability of drug concentrations verified via gas chromatography/mass spectroscopy (GC/MS).

Technological Characteristics

Multi-level liquid calibrators; human urine matrix; Δ9-THC-COOH analyte; added preservatives. Concentrations verified by GC/MS. Designed for use with automated clinical chemistry analyzers.

Indications for Use

Indicated for calibration of Roche cannabinoid assays in human urine samples using automated clinical chemistry analyzers. Prescription use only.

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

• Roche Abuscreen OnLine THC Calibration Pack 20 calibrators (K961726)

Submission Summary (Full Text)

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

A. 510(k) Number:

B. Analyte:
Cannabinoid

C. Type of Test:
Cannabinoid calibrators.

D. Applicant:
Roche Diagnostics Corporation

E. Proprietary and Established Names:
Preciset DAT THC calibrator
Preciset DAT THC 20 calibrator

F. Regulatory Information:
1. Regulation section:
CFR § 862.3200, Clinical toxicology calibrator, Drug Specific
2. Classification:
Class II
3. Product Code:
DLJ,
4. Panel:
Toxicology (91)

G. Intended Use:
1. Intended Use(s):
Refer to the Indications for Use.
2. Indication(s) for use:
The Preciset DAT THC calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.
The Preciset DAT THC 20 calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.
3. Special condition for use statement(s):
Prescription Use Only
4. Special instrument Requirements:
Automated clinical chemistry analyzers

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H. Device Description:

Preciset DAT THC calibrators contain 6 levels of $\Delta^9$ – THC-COOH, prepared by the quantitative addition of drug to drug free urine. Target concentration levels included are 0, 20, 50, 100, and $300\mathrm{ng / ml}$ of cannabinoids with calibrators contained in bottles 1-6 at five ml for each level.

Preciset DAT THC calibrators contain 5 levels of $\Delta^9$ – THC-COOH, prepared by the quantitative addition of drug to drug free urine. Target concentration levels included are 0, 10, 20, 40, and $100\mathrm{ng / ml}$ of cannabinoids with calibrators contained in bottles 1-5 at five ml for each level.

I. Substantial Equivalence Information:

1. Predicate device name(s):
Roche Abuscreen OnLine THC Calibration Pack 20 calibrators
2. Predicate K number(s):
K961726
3. Comparison with predicate:

| Similarities & Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Intended for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers. | Intended for calibration of the Roche test system for the qualitative and semi-quantitative determination of cannabinoids in human urine on automated chemistry analyzers |
| Matrix | Human urine with added preservative | Human urine with added preservative |
| Calibrator levels | Preciset DAT THC
Cannabinoida levels: 0, 20, 50, 100, 200, 300 ng/ml
Preciset DAT THC 20
Cannabinoida levels: 0, 10, 20, 40, 100 ng/ml | Cannabinoida levels q, 20, 50, 100, 150 ng/ml |

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

Roche Risk Management policy and ISO 14971:2000; Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Calibrators

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

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c. Traceability (controls, calibrators, or method): Drug concentrations in the Preciset DAT THC calibrators and Preciset DAT THC 20 calibrators are verified by gas chromatography/mass spectroscopy (GC/MS).

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

M. Conclusion:

Based upon the information provided, I recommend that the Roche Preciset DAT THC calibrator & Preciset DAT THC 20 calibrator be found substantially equivalent with similar defined products based upon 21 CFR 862. § 862.3200, Clinical toxicology calibrator, Drug Specific