Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
K153474 · Biochemical Diagnostics, Inc. · DIF · Feb 23, 2016 · Clinical Toxicology
Device Facts
Record ID
K153474
Device Name
Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
Applicant
Biochemical Diagnostics, Inc.
Product Code
DIF · Clinical Toxicology
Decision Date
Feb 23, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.3280
Device Class
Class 1
Indications for Use
The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
Device Story
Detectabuse® Liquid Control Urine is a stabilized human-based urine product used as an in vitro diagnostic quality control material. It is intended for use in clinical laboratories to monitor the precision of toxicology testing procedures. The device consists of positive controls, gravimetrically spiked with reference drug standards and metabolites, and negative controls, certified negative via immunoassay, GC/MS, or LC/MS. The product is supplied in liquid form and contains sodium azide or a proprietary preservative as a stabilizer. Laboratory personnel use the control to verify the performance of their toxicology assays. By comparing test results of the control against expected values, clinicians ensure the accuracy and reliability of patient drug testing, facilitating informed clinical decision-making regarding toxicology screening.
Clinical Evidence
No clinical data. Bench testing only. Stability studies confirmed performance at 2-8°C (31-day open vial; 3-year closed vial) and -10 to -20°C (up to 4 years). Accuracy validated by SAMHSA/CAP certified laboratories using GC/MS, LC/MS, and immunoassay. Acceptance criteria for target values generally ±15%.
Technological Characteristics
Stabilized human-based urine matrix. Preservatives: sodium azide (<1%) or proprietary manufacturer-approved preservative. Form: liquid. Storage: 2-8°C or -10 to -20°C. Analyte list includes various drugs of abuse, metabolites, and physiological markers (pH, specific gravity, creatinine).
Indications for Use
Indicated for use as quality control urine to monitor precision of laboratory urine toxicology testing procedures. Designed for use under supervision of healthcare professionals as part of good laboratory practices. Compatible with quantitative and qualitative drug detection procedures sensitive to control constituents.
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
Detectabuse® Liquid Control Urine (k121122)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION MEMORANDUM
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k153474
B. Purpose for Submission:
New Device
C. Measurand:
Quality control material for Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine(PCP), Morphine, Morphine -3-glucuronide, 6-Monoacetylmorphine(6-MAM), Codeine, Oxycodone, Buprenorphine, Fentanyl, d-Amphetamine, d-Methamphetamine, 3, 4-Methylenedioxymethamphetamine (MDMA), 3, 4-Methylenedioxyamphetamine (MDA), 3, 4-Methylenedioxy-N-ethylamphetamine (MDEA), Secobarbital, Phenobarbital, Butalbital, Oxazepam, Nordiazepam, Methadone, EDDP, Methaqualone, Propoxyphene, Norproxyphene, Nortriptyline, Cotinine, Ethanol, Creatinine, pH, Specific Gravity Amphetamines, Cannabinoids, Opiates, Barbiturates, Benzodiazepines, Hydrocodone, Buprenorphine glucuronide, Lysergic Acid, Acetaminophen, Tramadol
D. Type of Test:
Not applicable
E. Applicant:
Biochemical Diagnostics, Inc.
F. Proprietary and Established Names:
Detectabuse® Stat-Screen® Liquid Control Urine
Detectabuse® Liquid Control Urine, AU/NZ
Detectabuse® Liquid Control Urine, Immunoassay Series
Detectabuse® Liquid Control Urine, Confirm Series
Detectabuse® Liquid Control Urine, GC/MS
Detectabuse® Liquid Control Urine Series, Single or Multi-Constituent
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G. Regulatory Information:
1. Regulation section:
21 CFR 862.3280, Clinical toxicology control material
2. Classification:
Class I, Reserved
3. Product code:
DIF
4. Panel:
Toxicology (91)
H. Intended Use:
1. Intended use(s):
See indication for use(s)
2. Indication(s) for use:
The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.
3. Special conditions for use statement(s):
This is an in vitro diagnostic device
For prescription use only
4. Special instrument requirements:
Not applicable
I. Device Description:
The Detectabuse® Liquid Controls
Each bottle contains stabilized human based urine. The positive urine controls have been gravimetrically spiked with reference drug standards and /or appropriate metabolites. The negative controls are certified negative by a combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on the target sheets. The products contain less than 1%
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sodium azide as a preservative. For assays sensitive to such as ELISA we substitutes a proprietary preservative approved by the manufacturers and DEA.
# J. Substantial Equivalence Information:
1. Predicate device name(s): Detectabuse® Liquid Control Urine
2. Predicate 510(k) number(s): k121122
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device Detectabuse® liquid Control Urine (k153474) | Predicate Device Detectabuse® liquid Control Urine (k121122) |
| Intended Use | Quality control urine to monitor the performance of laboratory toxicology testing procedure | Same |
| Form | Liquid | Same |
| Matrix | Human urine | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device Detectabuse® liquid Control Urine (k153474) | Predicate Device Detectabuse® liquid Control Urine (k121122) |
| Analytes | Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine(PCP), Morphine, Morphine -3-glucuronide, 6-Monoacetylmorphine(6-MAM), Codeine, Oxycodone, Buprenorphine, Fentanyl, d-Amphetamine, d-Methamphetamine, 3, 4-Methylenedioxymethamphetamine (MDMA), 3, 4-Methylenedioxyamphetamine (MDA), 3, 4-Methylenedioxy-N-ethylamphetamine (MDEA), Secobarbital, Phenobarbital, Butalbital, Oxazepam, | Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine(PCP), Morphine, Morphine -3-glucuronide, 6-Monoacetylmorphine(6-MAM), Codeine, Oxycodone, Buprenorphine, Fentanyl, d-Amphetamine, d-Methamphetamine, 3, 4-Methylenedioxymethamphetamine (MDMA), 3, 4-Methylenedioxyamphetamine (MDA), 3, 4-Methylenedioxy-N-ethylamphetamine (MDEA), Secobarbital, Phenobarbital, Butalbital, Oxazepam, |
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| Differences | | |
| --- | --- | --- |
| Item | Candidate Device
Detectabuse® liquid Control Urine
(k153474) | Predicate Device
Detectabuse® liquid Control Urine
(k121122) |
| | Nordiazepam, Methadone, EDDP, Methaqualone, Propoxyphene, Norproxyphene, Nortriptyline, Cotinine, Ethanol, Creatinine, pH, Specific Gravity Amphetamines, Cannabinoids, Opiates, Barbiturates, Benzodiazepines, Hydrocodone, , , Buprenorphine glucuronide, Lysergic Acid, , Acetaminophen, Tramadol | Nordiazepam, Methadone, EDDP, Methaqualone, Propoxyphene, Norproxyphene, Nortriptyline, Cotinine, Ethanol, Creatinine, pH, Specific Gravity |
| Storage | Closed vial stable for 36 months when stored at 2-8°C with the exception of oxazepam (oxazepam stable for 6 months), 48 months when stored at -10 to -20°C. Open vial are stable for 31 days when stored at 2-8°C. | Closed vial are stable for 36 months when stored at 2-8°C with the exception of oxazepam, 48 months when stored at -10 to -20°C and protected from light with the exception of oxazepam. Open vial are stable for 30 days when stored at 2-8°C |
K. Standard/Guidance Document Referenced (if applicable):
None were referenced
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):
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5
Traceability:
The controls are validated by certified independent laboratories by using either GC/MS, LC/MS, HPLC, or Immunoassay screening. The controls are manufactured using reference standards purchased from commercial vendors. Accuracy is certified by purity determination using analytical tools including GC/MS, LC/MS, and NMR. Gravimetric preparation is accomplished using balances calibrated with weights that are traceable to National Institute of Standards and Technology (NIST).
Value Assignment:
The following procedure was used for value assignment
a. Assay Methodology used to assign values:
Certified Independent laboratories test by GC/MS, LC/MS, or Immunoassay screening depending on validated test method that is in use at time of testing.
b. Data Collection:
A minimum of 3 data points are collected for each assay. Data collected from at least two test sites, testing performed within 1 week of receipt of test samples.
Stability:
The stability protocols for open and closed vial were reviewed and found acceptable. The testing supports closed vial stability for 36 months when stored at 2-8°C with the exception of oxazepam (oxazepam is stable for 6 months) and 48 months when stored at -10 to -20°C. Open vials are stable for 31 days when stored at 2-8°C and 31 days when stored at room temperature (18-21°C).
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable
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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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Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
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.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
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).
2. The results table
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.
Where do you find a device's intended use without opening the PDF?
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.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
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?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
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What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
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.
In the predicate graph, why are commonly predicated devices worth reading?
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.
