Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology screening procedures.
Device Story
Liquichek Urine Toxicology Control is a liquid, ready-to-use quality control material derived from human urine; supplemented with preservatives, stabilizers, animal-derived constituents, and specific drugs of abuse/metabolites. Used in clinical laboratories to monitor the precision of toxicology screening procedures. The device provides known concentrations of analytes—including cannabinoids, cocaine, ethanol, LSD, methadone, methaqualone, opiates, oxazepam, phencyclidine, propoxyphene, secobarbital, and d-methamphetamine—to verify assay performance. Healthcare providers use the control results to validate the accuracy and reliability of patient sample testing. The product is stored frozen (-20°C to -70°C) and has established stability claims for open and closed vials.
Clinical Evidence
No clinical data. Stability studies were performed to validate shelf life (2 years at -20°C to -70°C), open vial stability (30 days at 2-8°C), and closed vial thawed stability (45 days at 2-8°C).
Technological Characteristics
Human urine matrix; liquid form; ready-to-use. Contains preservatives (antibiotic cocktail). Analytes: cannabinoids, cocaine, ethanol, LSD, methadone, methaqualone, opiates, oxazepam, phencyclidine, propoxyphene, secobarbital, d-methamphetamine. Storage: -20°C to -70°C (unopened); 2°C to 8°C (open/thawed). Stability: 30 days open vial, 45 days closed vial (thawed), 2 years shelf life.
Indications for Use
Indicated for use as a quality control material in laboratory urine toxicology screening procedures to monitor precision. No specific patient population, age, or gender restrictions apply as it is a laboratory control product.
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
Liquichek Urine Toxicology Control (Screen Series) (K033924)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
K120504
B. Purpose for Submission:
New Device
C. Analyte:
Quality control materials for Cannabinoids (delta-9-THC), cocaine (benzoylecgonine), ethanol, lysergic acid diethlamide (LSD), methadone, methaqualone, opiates (morphine, free), oxazepam, phencyclidine (PCP), propoxyphene, secobarbital, d-Methamphetamine
D. Type of Test:
Not applicable
E. Applicant:
Bio-Rad Laboratories
F. Proprietary and Established Names:
Liquichek Urine Toxicology Control, Level S1O
Liquichek Urine Toxicology Control, Level S1O, MiniPak
Liquichek Urine Toxicology Control, Level S2O
Liquichek Urine Toxicology Control, Level S2O, MiniPak
Liquichek Urine Toxicology Control, Level S1O Low Opiate
Liquichek Urine Toxicology Control, Level S1O Low Opiate, MiniPak
Liquichek Urine Toxicology Control, Level S2O Low Opiate
Liquichek Urine Toxicology Control, Level S1O Low Opiate, MiniPak
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)
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H. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology screening procedures.
3. Special condition for use statement(s):
None
4. Special instrument Requirements:
Not applicable.
I. Device Description:
The product is prepared from human urine with addition of preservatives, stabilizers, constituents of animal origin, abused drugs and their metabolites. It is a liquid ready to use quality control material.
The serum of each donor, who contributed urine for this product, was tested by FDA accepted methods and found to be 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 (Screen Series)
2. Predicate K number(s):
K033924
3. Comparison with predicate:
Showing in table 1, both devices have same matrix and both are quality control materials that measure similar analytes. These two devices are different in that the candidate device added two novel analytes - oxazepam and d-methamphetamine - and removed three analytes - nordiazepam, nortriptyline (TCA), and d-amphetamine. Since the preservative of the candidate device is a cocktail of antibiotics and it does not contain any hazardous materials, the candidate device does not require the hazard symbol.
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Table 1. Similarities and differences between candidate and predicate device.
| Characteristics | Liquichek Urine Toxicology Control (New Device) | Liquichek Urine Toxicology Control (Screen Series) (Predicate Device, K033924) |
| --- | --- | --- |
| Similarities | | |
| Intended Use | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology screening procedures. | Liquichek Urine Toxicology Control (Screen Series) is intended for use as quality control urine to monitor the precision of laboratory urine toxicology screening procedures. |
| Matrix | Human Urine | Human Urine |
| Form | Liquid | Liquid |
| Open vial stability | 30 days at 2 °C to 8 °C | 30 days at 2 °C to 8 °C |
| Differences | | |
| --- | --- | --- |
| Storage unopened (shelf Life) | -20 °C to -70 °C until expiration date | 2 °C to 8 °C until expiration date |
| Closed Vial (Thawed) Stability | 45 days at 2 °C to 8 °C | No Claim |
| Levels | Level S10, S20, S10 Low Opiate, S20 Low Opiate | Level S1, S2, S3, S1 Low Opiate, S2 Low Opiate |
| Analytes | Contains | Contains |
| | Cannabinoids (delta-9-THC) | Cannabinoids (delta-9-THC) |
| | Cocaine (benzoylecgonine) | Cocaine (benzoylecgonine) |
| | Ethanol | Ethanol |
| | Lysergic acid diethamide (LSD) | Lysergic acid diethamide (LSD) |
| | Methadone | Methadone |
| | Methaqualone | Methaqualone |
| | Opiates (morphine, free) | Opiates (morphine, free) |
| | Phencyclidine (PCP) | Phencyclidine (PCP) |
| | Propoxyphene | Propoxyphene |
| | Secobarbital | Secobarbital |
| | Oxazepam | Nordiazepam |
| | d-Methamphetamine | Nortriptyline (TCA) |
| | Does not contain: | d-Amphetamine |
| | Nordiazepam | Does not contain: |
| Nortriptyline (TCA) | Oxazepam | |
| d-Amphetamine | d-Methamphetamine | |
K. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards in their submission.
L. Test Principle:
Not applicable.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable.
b. Linearity/assay reportable range:
{3}
Not applicable.
c. Traceability (controls, calibrators, or method):
Candidate product consists of eight control materials. Controls are human urine spiked with known concentrations of drugs which were gravimetrically prepared. Expected concentrations were verified by reference laboratories. Minimum number of laboratories, replicate measurements, or assay systems is not, however, specified.
Although GC/MS and Enzyme Immunoassay (EIA) analysis is performed during stability studies, (see below), the traceability of control results to GC/MS and EIA is not specified or discussed by the sponsor.
Stability studies are summarized for these controls. Product claims include: (1) open vial: 30 days at 2°C to 8°C, (2) closed vial (Thawed): 45 days at 2°C to 8°C, and (3) shelf life stability: 2 years at -20°C to -70°C. The sponsor specifies the frequency of testing, the method for testing the materials (GC/MS or EIA), environmental conditions of storage, and acceptance criteria for the study (less than 10% variance comparing to time zero). Accelerated stability studies were employed by incubating controls at elevated temperatures (i.e. 25°C, 16°C, 5°C, etc.) to detect alterations in product performance more rapidly than would be seen under normal storage conditions of -20°C to -70°C. Estimated expiration date was predicted using a stability model with activation energy of the 20-kCal/mol or Arrhenius Model. On-going real time studies are long-term and being performed. All procedures appear to be compliance with standard for the industry.
Representative values of the materials are provided and look appropriate.
d. Detection limit:
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.
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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 available.
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 substantial equivalence decision.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
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
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
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.
