DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
K062191 · Dade Behring, Inc. · DIF · Aug 21, 2006 · Clinical Toxicology
Device Facts
Record ID
K062191
Device Name
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
Applicant
Dade Behring, Inc.
Product Code
DIF · Clinical Toxicology
Decision Date
Aug 21, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.3280
Device Class
Class 1
Indications for Use
The Dimension Vista™ System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System. The Dimension Vista™ System Drugs of Abuse Negative Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.
Device Story
Liquid, human urine-based quality control materials; used to monitor performance of drugs of abuse assays on Dimension Vista System. Positive control contains analytes above assay cutoff; negative control contains analytes below cutoff. Ready-to-use vials; no preparation required. Healthcare providers use these controls to verify assay accuracy and precision during routine clinical toxicology testing. Values assigned via GC/MS reference testing.
Clinical Evidence
No clinical data. Bench testing only. Value assignment performed via GC/MS reference testing; stability protocols and acceptance criteria were evaluated and found acceptable.
Technological Characteristics
Liquid, human urine-based multi-analyte control. Constituents: D-methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor-Δ⁹-THC-9-COOH. Traceable to GC/MS reference testing. Designed for use on Dimension Vista System.
Indications for Use
Indicated for use as quality control material for drugs of abuse testing (AMPH, BARB, BENZ, COC, METH, OPI, PCP, THC) on the Dimension Vista System. For prescription use.
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
Dimension® Drugs of Abuse Positive Control (k950138)
Dimension® Drugs of Abuse Negative Control (k950138)
Submission Summary (Full Text)
{0}
1
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k062191
B. Purpose for Submission:
510(k) premarket notification package to manufacture and market the Dimension Vista™ System Drugs of Abuse Positive Control (UDAT CON(+)-KC515) and Negative Control (UDAT CON(-)-KC516).
C. Measurand:
Control Materials for Amphetamine/Methamphetamine, Barbiturate, Benzodiazepines, Cocaine Metabolite, Methadone, Opiates, Phencyclidine, and Cannabinoids.
D. Type of Test:
Control Materials
E. Applicant:
Dade Behring, Inc.
F. Proprietary and Established Names:
Dimension Vista™ Drugs of Abuse Positive Control
Dimension Vista™ Drugs of Abuse Negative Control
G. Regulatory Information:
1. Regulation section:
862.3280 - Clinical toxicology control material
2. Classification:
Class I
3. Product code:
{1}
Drug mixture control materials (DIF)
4. Panel:
Toxicology (91)
# H. Intended Use:
1. Intended use(s):
See Indication(s) for use below.
2. Indication(s) for use:
The Dimension Vista™ System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.
The Dimension Vista™ System Drugs of Abuse Negative Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.
3. Special conditions for use statement(s):
For prescription use
4. Special instrument requirements:
Dimension Vista System
# I. Device Description:
The Dimension Vista™ System Drugs of Abuse Positive Control is a liquid, multi-analyte, human urine-based product for the following constituents at above the cutoff levels of the methods:
| Analyte | Constituent |
| --- | --- |
| Amphetamine/Methamphetamine | D-methamphetamine |
| Barbiturate | Secobarbital |
| Benzodiazepines | Nordiazepam |
| Cocaine Metabolite | Benzoylecgonine |
| Methadone | Methadone |
{2}
3
| Analyte | Constituent |
| --- | --- |
| Opiates | Morphine |
| Phencyclidine | Phencyclidine |
| Cannabinoids | 11-nor-Δ⁹-THC-9 –COOH |
The kit consists of six vials which are ready for use (no preparation is required). The volume per vial is 2.5 mL.
The Dimension Vista™ System Drugs of Abuse Negative Control is a liquid, multi-analyte, human urine-based product containing the following constituents below the cutoff levels of the methods:
| Analyte | Constituent |
| --- | --- |
| Amphetamine/Methamphetamine | D-methamphetamine |
| Barbiturate | Secobarbital |
| Benzodiazepines | Nordiazepam |
| Cocaine Metabolite | Benzoylecgonine |
| Methadone | Methadone |
| Opiates | Morphine |
| Phencyclidine | Phencyclidine |
| Cannabinoids | 11-nor-Δ⁹-THC-9 –COOH |
The kit consists of six vials which are ready for use (no preparation is required). The volume per vial is 2.5 mL
## J. Substantial Equivalence Information:
1. Predicate device name(s):
Dimension® Drugs of Abuse Positive Control
Dimension® Drugs of Abuse Negative Control
2. Predicate 510(k) number(s):
k950138
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Amphetamines /Methamphetamines (AMPH), Barbiturates | Amphetamines /Methamphetamines (AMPH), Barbiturates |
{3}
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC). | (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC). |
| Form | Liquid | Liquid |
| Traceability | GC/MS | GC/MS |
| Matrix | Human urine based | Human urine based |
| Number of levels | One positive, one negative | One positive, one negative |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | The Dimension Vista™ System Drugs of Abuse Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension VistaTM System. | The Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the following methods packaged in Flex® reagent cartridges: Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC). |
# K. Standard/Guidance Document Referenced (if applicable):
FDA Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final
FDA Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
FDA Guidance for Industry - Points to Consider Guidance Document on
{4}
Assayed and Unassayed Quality Control Material
FDA Guidance for Industry and FDA Staff – Bundling Multiple Devices or Multiple Indications in a Single Submission; Draft
CEN 13640 Stability testing of In-Vitro Diagnostic Devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices
L. Test Principle:
Not Applicable
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility: Not Applicable
b. Linearity/assay reportable range: Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability
The assigned values of the Dimension Vista™ System Drugs of Abuse Positive Control and the Dimension Vista™ System Drugs of Abuse Negative Control are traceable to Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing.
Value Assignment
Calculated quantities of D-Methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, and 11-nor-Δ⁹-THC-9-COOH high purity stock solutions are added to drug free normal human urine to target concentrations for each of the Negative and Positive Controls. The Negative and Positive Bulk Products are tested by GC/MS and any analyte that is out of the acceptable GC/MS range is adjusted and retested. Values are assigned to the controls once the GC/MS results are in the acceptable ranges.
Stability
Protocols and acceptance criteria were described and found to be acceptable.
d. Detection limit:
5
{5}
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable
2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable
4. Clinical cut-off:
Not Applicable
5. Expected values/Reference range:
Not Applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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Reading rule for every project: how many summaries do you read in full?
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
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Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
