CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 by BOEHRINGER MANNHEIM CORP.

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 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.

AI/ML Overview

The provided text is a summary for a 510(k) premarket notification for two quality control devices, the Multi-Drug Control Set and the Specialty Control Set 1. Such summaries focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device.

Therefore, the document does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study report would for a diagnostic or therapeutic device. Instead, it aims to show that the new devices are as safe and effective as already marketed predicate devices.

However, based on the information provided, we can infer some "performance characteristics" and "acceptance criteria" related to the substantial equivalence claim.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature (Implied Acceptance Criteria)	Device Performance (Reported)
For Multi-Drug Control Set (vs. MAS Liquid Urinalysis Controls):
Same Matrix as Predicate	Yes, "Same matrix."
Same Composition as Predicate	Yes, "Same composition"
Same Manufacturer as Predicate	Yes, "Same manufacturer." (This refers to both devices being from Boehringer Mannheim, implying consistency in manufacturing processes as compared to the predicate, though the predicate itself is MAS)
Same Confirmatory Method as Predicate	Yes, "Same confirmatory method."
Same Open Vial Stability Claim as Predicate	Yes, "Same open vial stability claim."
Control Target Concentrations	See tables in the original document for detailed comparison. The values are similar but not identical for all analytes and levels, supporting the "modification" aspect. For example, MAS Liquid Urinalysis Controls have an additional "4" level for LSD, and some target concentrations vary slightly (e.g., Benzoylecgonine High: 375 ng/mL for modified Multi-Drug vs. 360 ng/mL for MAS). The claim is likely that the ranges or intended functionality remain equivalent despite slight numeric differences.
Intended Use	"Monitoring assays for drugs of abuse." (Modified Multi-Drug) vs. "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." (MAS Liquid Urinalysis Controls). The intended uses are functionally very similar.
Dose Verification (Accuracy of Spike)	"Confirmation of target doses by GC/MS." (This is a performance characteristic, implying the spiked concentrations were verified to be correct).
Open Vial Stability	"Equivalent performance as the predicate device." (This confirms the claim above.)

For Specialty Control Set 1 (vs. Multi-Drug Control Set):
Same Matrix as Predicate	Yes, "Same matrix."
Same Composition as Predicate	Yes, "Same composition"
Same Manufacturer as Predicate	Yes, "Same manufacturer."
Same Confirmatory Method as Predicate	Yes, "Same confirmatory method."
Same Open Vial Stability Claim as Predicate	Yes, "Same open vial stability claim."
Control Target Concentrations	See tables in the original document for detailed comparison. Concentrations differ as Specialty Control Set 1 is a different product with different target levels for the included drugs. For example, Benzoylecgonine Low is 112 ng/mL for Specialty Control Set 1 vs. 225 ng/mL for Multi-Drug Control Set. The claim is substantial equivalence despite different specific concentration targets as both serve as controls.
Intended Use	"Monitoring assays for drugs of abuse." (Modified Specialty Control Set 1) vs. "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." (Multi-Drug Control Set). Both essentially serve the same function of monitoring drugs of abuse assays.
Dose Verification (Accuracy of Spike)	"Confirmation of target doses by GC/MS."
Open Vial Stability	"Equivalent performance as the predicate device."

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" sample size in terms of number of controls or batches tested for the performance characteristics like "Dose verification" or "Open Vial Stability Study." These are generally internal validation studies, not large clinical trials.
Data provenance (country of origin, retrospective/prospective) is not mentioned. These are quality control materials, so the provenance of the internal validation data is usually less emphasized than patient data for clinical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable/provided in the context of this 510(k) summary. "Ground truth" in this context refers to the known concentrations of the spiked drugs. This is established chemically during manufacturing and verified by analytical methods like GC/MS, not by human experts interpreting results. The experts involved would be analytical chemists.

4. Adjudication method for the test set:

Not applicable/provided. Adjudication methods are typically associated with human interpretation tasks or clinical endpoints, which is not the primary focus here. The "dose verification" would involve comparing instrumental measurements to expected values.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a quality control material for drug assays, not an AI-powered diagnostic or screening tool that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a reagent/control, not an algorithm.

7. The type of ground truth used:

The ground truth for the performance characteristics (dose verification, stability) is the known, spiked concentration of each drug within the control material, analytically verified by methods such as GC/MS (Gas Chromatography/Mass Spectrometry). For QC materials, this is a chemical, not an observational, ground truth.

8. The sample size for the training set:

Not applicable/provided. This device is a quality control material, not a machine learning algorithm that requires a "training set" in the conventional sense. The controls are manufactured to specific concentrations.

9. How the ground truth for the training set was established:

Not applicable. As explained above, there is no "training set" for an algorithm. The "ground truth" (i.e., the correct concentration values) for the control materials themselves is established during manufacturing by precise spiking and then verified using analytical methods like GC/MS. The document states that the controls are "quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by CEDIA," confirming that the establishment of values is an analytical and calibration process.

Summary

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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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Differences :

Substantial equivalence, continued

Feature	Modified Multi-DrugControl Set	MAS Liquid UrinalysisControls
Control TargetConcentrations:	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 fordrugs of abuse.	Multi-analyte Drugs ofAbuse Controls areintended for use as aconsistent test sample ofknown concentration formonitoring assayconditions in aquantitative andqualitative analyses ofpatient urine specimensfor drugs and drugmetabolites.

Performance Characteristics:

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· Dose verification: Confirmation of target doses by GC/MS.

· Open Vial Stability Study: Equivalent performance as the predicate device

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6. Substantial Equivalence, continued

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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

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Differences, continued:

Feature	Modified Specialty Control Set 1		Multi-Drug Control Set
Control TargetConcentrations:	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 fordrugs of abuse.		The Multi-Drug ControlSet is used as unassayedcontrol material with drugsof abuse assays foramphetamines,barbiturates,benzodiazepines, cocainemetabolite, methadone,methaqualone, opiates,phencyclidine, andpropoxyphene.

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Performance Characteristics:

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· Dose verification: Confirmation of target doses by GC/MS
· Open Vial Stability Study: Equivalent performance as the predicate device

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Regulation Number and Section

§ 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.