TDM CONTROL SET, MODEL CAT# 04521536

K070200 · Roche Diagnostics Corp. · JJY · Mar 19, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070200
• Device Name: TDM CONTROL SET, MODEL CAT# 04521536
• Applicant: Roche Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The TDM Control Set is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet.

Device Story

TDM Control Set is a liquid quality control material based on human serum containing 17 therapeutic drugs, preservatives, and stabilizers. It is used in clinical laboratory settings on Roche/Hitachi and COBAS INTEGRA analyzers to monitor the accuracy and precision of quantitative assays. The device provides three levels for each drug and two levels for serum barbiturates. The barbiturate assay utilizes the cross-reactivity of phenobarbital already present in the control to assign target values. Healthcare providers use the control results to verify that the analyzer's performance remains within specified ranges, ensuring the reliability of patient therapeutic drug monitoring results.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate the modification of adding serum barbiturates to the analyte list.

Technological Characteristics

Liquid control based on human serum with added therapeutic drugs, preservatives, and stabilizers. Provides three levels for 17 drugs and two levels for serum barbiturates. Analyte concentrations are lot-specific and provided in an accompanying value sheet. Designed for use on Roche/Hitachi and COBAS INTEGRA clinical chemistry analyzers.

Indications for Use

Indicated for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers to monitor accuracy and precision for 17 therapeutic drugs (acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, vancomycin) and serum barbiturates.

Regulatory Classification

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.

Predicate Devices

• TDM Control Set (K060429)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k070200

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) K060429
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for: the addition of serum barbiturates to the list of analytes. This addition uses the already present phenobarbital to make up the serum barbiturates value.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.