(25 days)
Not Found
No
The summary describes a quality control material for drug assays, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as quality control material used to monitor drugs of abuse assays, not for treatment or therapy.
No
The device is described as "quality control material to monitor drugs of abuse assays," indicating it is used to verify the performance of diagnostic tests, rather than directly diagnosing a patient's condition.
No
The device description clearly states it is manufactured using human urine, drugs, stabilizers, and preservatives, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are "to be used as quality control material to monitor drugs of abuse assays." This indicates that the device is used in vitro (outside the body) to assess the performance of other diagnostic tests (drugs of abuse assays).
- Device Description: The description mentions that the controls are manufactured using human urine and are used to quality control against in-house reference calibrators. This further supports its use in a laboratory setting for diagnostic purposes.
- Performance Studies: The mention of "Dose verification" and "Open Vial Stability Study" are typical performance studies conducted for IVD devices to ensure their accuracy and reliability.
- Predicate Devices: The listed predicate devices (K935062 and K951135) are also IVD devices (specifically urinalysis controls), which is a strong indicator that this device falls into the same category.
The device is a quality control material used in vitro to monitor the performance of other diagnostic tests, which is a core function of an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
- Dose verification: Confirmation of target doses by GC/MS.
- Open Vial Stability Study: Equivalent performance as the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 862.3280 Clinical toxicology control material.
(a)
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.(b)
Classification. Class I (general 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.
0
K965127 な ax. 17, 1997 ) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1. Submitter 2400 Bisso Lane name. Concord, CA 94524-4117 address, (510) 674-0690 extension 8413 contact Fax number: (510) 687-1850 Contact Person: Yvette Lloyd Date Prepared: December 20, 1994 Proprietary name: Multi-Drug Control Set, Speciality Control Set 1 2. Device name Common name: Liguid Drugs of Abuse Controls Classification name: Quality Control material (unassayed), Urinalysis Controls (unassaved) 3. The Boehringer Mannheim modified Multi-Drug Control Set is substantially Predicate eduivalent to the Medical Analysis Systems (MAS) Liquid Urinalysis device Controls (K935062). The Boehringer Mannheim modified Specialty Control Set 1 is substantially equivalent to the Multi-Drug Control Set (K951135). 4. The Multi-Drug Control Set and the Specialty Control Set 1 are manufactured Device using human urine, multiple drugs of abuse, stabilizers, and preservatives. Description 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. Continued on next page
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| 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 in provided in attachment 6. | |
| Similarities: Multi-Drug Control and MAS Liquid Urinalysis Controls | |
| Same matrix.Same composistionSame manufacturer.Same confirmatory methodSame open vial stability claim | |
| Continued on next page |
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2
Differences :
- Substantial equivalence, continued
| 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 | | |
| Rhencyclidine | 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
. "
Continued on next page
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રું જ
6. Substantial Equivalence, continued
. .
Similarities: Specialty Control Set 1 and Multi-Drug Control Set · Same matrix. .
- · Same composistion
- · Same manufacturer
.
ﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
- · Same confirmatory method
- Same open vial stability claim
: 1
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Continued on next page
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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. |
ﭘﺮ ﭘ .
Performance Characteristics:
. "
-1
. · .
- · Dose verification: Confirmation of target doses by GC/MS
- · Open Vial Stability Study: Equivalent performance as the predicate device
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