Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.
Device Story
Liquichek Urine Toxicology Control is a liquid-form quality control material derived from human urine; supplemented with drugs of abuse, metabolites, preservatives, and stabilizers. It serves as a reference to monitor the performance of laboratory urine toxicology confirmatory procedures. The device is used by laboratory personnel in clinical settings. It contains a mixture of analytes including amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, ethanol, LSD, methadone, methaqualone, opiates, phencyclidine, propoxyphene, creatinine, and MDMA/MDA/MDEA. Reference values are established via gravimetric methods and GC analysis. The product is tested for HBsAg, HCV, and HIV-1/HIV-2. It provides laboratories with a standardized sample to verify the accuracy and reliability of their toxicology testing workflows.
Clinical Evidence
No clinical data. Bench testing only. Stability studies (open and closed vial) were performed using GC/MS to verify recovery within +/- 10% of Tzero values. Accelerated stability testing predicted a 4-year shelf life.
Technological Characteristics
Liquid-form human urine matrix containing drugs of abuse, metabolites, preservatives, and stabilizers. Stored at 2-8°C. No software or electronic components.
Indications for Use
Indicated for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures in clinical laboratory settings.
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.
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
k050682
B. Purpose for Submission:
New Device
C. Analyte:
Urine Toxicology Control Material (Drug Mixture) for the following analytes:
Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital,
Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam,
Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone,
Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine,
Methylenedioxymethamphetamine (MDMA), Methylenedioxyamphetamine (MDA)
and Methylenedioxyethylamphetamine (MDEA).
D. Type of Test:
Control Material
E. Applicant:
Bio-Rad Laboratories
F. Proprietary and Established Names:
Liquichek Urine Toxicology Control
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:
91
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
Liquichek Urine Toxicology Control is intended for use as a quality control
urine to monitor the performance of laboratory urine toxicology confirmatory
procedures.
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3. Special condition for use statement(s):
N/A
4. Special instrument Requirements:
N/A
I. Device Description:
Liquichek Urine Toxicology Control is prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form and at several levels that are shown in the package insert. The control contains Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital, Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam, Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine, Methylenedioxymethamphetamine (MDMA), Methylenedioxyamphetamine (MDA) and Methylenedioxyethylamphetamine (MDEA). Gravimetric reference values and GC analyses are listed in the package insert.
The serum from each donor contributing urine for this product was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
J. Substantial Equivalence Information:
1. Predicate device name(s):
LiquiChek Urine Toxicology Control
2. Predicate K number(s):
k033404
3. Comparison with predicate:
This control material is similar in composition to the predicate device, except that the new device contains MDMA, MDA and MDEA in control level 1.
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Device Name | LiquiChek Urine Toxicology Control (Level 1) | LiquiChek Urine Toxicology (Level 1) |
| Intended Use | Intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. | Intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. |
| Matrix | Urine | Urine |
| Stability | 30 days once opened | 30 days once opened |
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Page 3 of 4
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Components | Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital, Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam, Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine, **Methylenedioxymethamphetamine (MDMA)**, **Methylenedioxyamphetamine (MDA) and Methylenedioxyethylamphetamine (MDEA)**. | Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital, Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam, Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine |
K. Standard/Guidance Document Referenced (if applicable):
None Referenced
L. Test Principle:
N/A. This 510(k) describes control material only.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
Value assignment is based on the average from triplicate analysis of control solutions at 3 reference laboratories using Gas Chromatography. Approximate GC and gravimetric values are listed in the package insert. The sponsor recommends that each laboratory using Liquichek controls should use these results only as a reference and should establish its own parameters for precision.
Open vial stability 2-8 °C was tested at 6 time points (1, 8, 14, 22, 29 and 36 days), the last of which (T<sub>final</sub>) extends to 20% longer than the expiration date of the control. Recovery of the sample tested at the last time point was compared, by GC/MS, to a freshly opened vial. Acceptance criteria are that T<sub>final</sub> must be within +/- 10% of the T<sub>zero</sub> value.
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Page 4 of 4
Closed stability was determined using an accelerated stability study and the product was predicted to have a 4 year shelf life when stored at 2-8 °C. The product was tested at three elevated temperatures and the shelf stability was predicted using a stability model with activation energy of 20-kCal/mole. Acceptance criteria are defined as recovery values at each time point that are within +/- 10% of the values determined for vials at the Tzero.
Real time closed vial stability are ongoing. Acceptance criteria are defined as recovery values at each time point that are within +/-10% of the values determined for vials stored at 2-8v °C or -20 °C.
d. Detection limit:
N/A
e. Analytical specificity:
N/A
f. Assay cut-off:
N/A
2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A
3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):
N/A
4. Clinical cut-off:
N/A
5. Expected values/Reference range:
N/A
N. 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
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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?
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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.
