CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
Device Facts
| Record ID | K965157 |
|---|---|
| Device Name | CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | DIF · Clinical Toxicology |
| Decision Date | Jan 17, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
Indications for Use
The modified Multi-Drug Specialty Control Set and the modified Specialty Control Set 1 are intended to be used as quality control material to monitor drugs of abuse assays.
Device Story
Multi-Drug Control Set and Specialty Control Set 1 are liquid quality control materials for drugs of abuse assays. Manufactured using human urine spiked with specific drugs, stabilizers, and preservatives. Used in clinical laboratories to monitor assay performance by providing samples of known concentration. Healthcare providers compare assay results against these known control values to ensure accuracy and consistency of patient urine drug testing. No automated processing or software involved.
Clinical Evidence
Bench testing only. Performance characteristics established via dose verification of target concentrations using GC/MS and open vial stability studies comparing the modified controls to the predicate devices.
Technological Characteristics
Liquid control material consisting of human urine, drugs of abuse, stabilizers, and preservatives. Unassayed. No electronic, software, or mechanical components.
Indications for Use
Indicated for use as quality control material to monitor drugs of abuse assays in human urine specimens.
Regulatory Classification
Identification
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
Predicate Devices
- Medical Analysis Systems (MAS) Liquid Urinalysis Controls (K935062)
- Multi-Drug Control Set (K951135)
Submission Summary (Full Text)
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K965157
Jan. 17, 1997
# Summary
## Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
## 1. Submitter name, address, contact
Boehringer Mannheim Corporation
2400 Bisso Lane
Concord, CA 94524-4117
(510) 674-0690 extension 8413
Fax number: (510) 687-1850
Contact Person: Yvette Lloyd
Date Prepared: December 20, 1996
## 2. Device name
Proprietary name: Multi-Drug Control Set, Speciality Control Set 1
Common name: Liquid Drugs of Abuse Controls
Classification name: Quality Control material (unassayed), Urinalysis Controls (unassayed)
## 3. Predicate device
The Boehringer Mannheim modified Multi-Drug Control Set is substantially equivalent to the Medical Analysis Systems (MAS), Liquid Urinalysis Controls (K935062). The Boehringer Mannheim modified Specialty Control Set 1 is substantially equivalent to the Multi-Drug Control Set (K951135).
## 4. Device Description
The Multi-Drug Control Set and the Specialty Control Set 1 are manufactured using human urine, multiple drugs of abuse, stabilizers, and preservatives. The drugs are appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by CEDIA.
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# 510(k) Summary, Continued
## 5. Intended use
The modified Multi-Drug Specialty Control Set and the modified Specialty Control Set 1 are intended to be used as quality control material to monitor drugs of abuse assays.
## 6. Substantial equivalence
The Boehringer Mannheim modified Multi-Drug Control Set and the modified Specialty Control Set 1 are modifications of existing products.
The Boehringer Mannheim modified Multi-Drug Control Set is substantially equivalent to the Medical Analysis Systems (MAS) Liquid Urinalysis Controls (K935062). The Boehringer Mannheim modified Specialty Control Set 1 is substantially equivalent to the Multi-Drug Control Set (K951135).
The following tables compare the modified Multi-Drug Control Set and the modified Specialty Control Set 1 with the respective predicate devices, Specialty Control Set 1 and the MAS Liquid urinalysis Controls. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.
**Similarities**: Multi-Drug Control and MAS Liquid Urinalysis Controls
- Same matrix
- Same composition
- Same manufacturer
- Same confirmatory method
- Same open vial stability claim
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510(k) Summary, Continued
## 6. Substantial equivalence, continued
## Differences:
| Feature | Modified Multi-Drug Control Set | | MAS Liquid Urinalysis Controls | | |
| --- | --- | --- | --- | --- | --- |
| Control Target Concentrations: | Control Level, ng/mL | | Control Level, ng/mL | | |
| | Low | High | 2 | 3 | 4 |
| LSD | 0.3 | 0.7 | 0.3 | 0.7 | 4.0 |
| Benzoylecgonine | 225 | 375 | 225 | 360 | 500 |
| d-Methamphetamine | 750 | 1250 | 750 | 1200 | 2000 |
| Methadone | 225 | 375 | 225 | 360 | 750 |
| Methaqualone | 225 | 375 | 225 | 360 | 750 |
| Morphine | 225 | 375 | 225 | 360 | 750 |
| Nitrazepam | 225 | 375 | n/a | | |
| Phencyclidine | 19 | 31 | 20 | 30 | 200 |
| Propoxyphene | 225 | 375 | 225 | 360 | 750 |
| Secobarbital | 225 | 375 | 150 | 250 | 1000 |
| Intended Use | Monitoring assays for drugs of abuse. | | Multi-analyte Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in a quantitative and qualitative analyses of patient urine specimens for drugs and drug metabolites. | | |
## Performance Characteristics:
- Dose verification: Confirmation of target doses by GC/MS.
- Open Vial Stability Study: Equivalent performance as the predicate device
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# 510(k) Summary, Continued
## 6. Substantial Equivalence, continued
Similarities: Specialty Control Set 1 and Multi-Drug Control Set
- Same matrix.
- Same composition
- Same manufacturer
- Same confirmatory method
- Same open vial stability claim
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510(k) Summary, Continued
## Differences, continued:
| Feature | Modified Specialty Control Set 1 | | Multi-Drug Control Set | |
| --- | --- | --- | --- | --- |
| Control Target Concentrations: | Control Level, ng/mL | | Control Level, ng/mL | |
| | Low | High | Low | High |
| Benzoylecgonine | 112 | 188 | 225 | 375 |
| Morphine | 1500 | 2500 | 225 | 375 |
| Methamphetamine | 375 | 625 | 750 | 1250 |
| Nitrazepam | 150 | 250 | 225 | 375 |
| Secobarbital | 150 | 250 | 225 | 375 |
| Intended Use | Monitoring assays for drugs of abuse. | | The Multi-Drug Control Set is used as unassayed control material with drugs of abuse assays for amphetamines, barbiturates, benzodiazepines, cocaine metabolite, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. | |
## Performance Characteristics:
- Dose verification: Confirmation of target doses by GC/MS.
- Open Vial Stability Study: Equivalent performance as the predicate device
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