The EasyRA Propoxyphene (PPX) reagent is intended for the qualitative and semi-quantitative measurement of Propoxyphene in human urine, using MEDICA’s EasyRA Chemistry Analyzer in clinical laboratories. The cut-off point is 300ng/ml, and the assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) or Liquid Chromatography/mass spectrometry (LC/MS) are the preferred confirmatory method. The semi-quantitative mode is intended to enable laboratories to determine the appropriate dilution of the specimen for confirmation by a reference method such as GCMS or LC/MS and to allow laboratories to establish effective quality control procedures for the PPX assay. Medica’s Propoxyphene (PPX) Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica’s PPX reagent on the EasyRA clinical chemistry analyzer. Medica’s Propoxyphene (PPX) QC Materials are intended for the validation of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica’s PPX reagent and PPX calibrator on the EasyRA clinical chemistry analyzer.
Device Story
EasyRA Propoxyphene assay is an enzymatic immunoassay for human urine; utilizes competitive binding between drug in sample and drug-labeled glucose-6-phosphate dehydrogenase (G6PDH) for fixed amount of monoclonal anti-propoxyphene mouse antibody. Enzyme activity inversely proportional to drug concentration; measured at 340 nm. Used in clinical laboratories on Medica EasyRA Chemistry Analyzer. Provides qualitative (positive/negative at 300ng/ml cutoff) or semi-quantitative results. Semi-quantitative mode assists in determining specimen dilution for confirmatory testing (GC/MS or LC/MS) and establishing quality control. Results are preliminary; require confirmation by specific chemical methods. Benefits include rapid screening for propoxyphene presence to guide clinical toxicology workflows.
Clinical Evidence
No clinical data. Bench testing only. Performance evaluated via precision (within-run/total CVs), linearity (50-800 ng/mL), and analytical specificity (endogenous substances and cross-reactivity). Method comparison against LC/MS showed 95% positive agreement and 100% negative agreement.
Indicated for qualitative and semi-quantitative measurement of Propoxyphene in human urine for clinical laboratory use. Provides preliminary analytical results at a 300ng/ml cut-off. Requires confirmation by GC/MS or LC/MS.
Regulatory Classification
Identification
A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Submission Summary (Full Text)
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1
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
K111363
B. Purpose for Submission:
New Device
C. Measurand:
Propoxyphene
D. Type of Test:
Qualitative and Semi-quantitative propoxyphene enzyme immunoassay
E. Applicant:
Medica Corp.
F. Proprietary and Established Names:
EasyRA Propoxyphene Reagent, EasyRA Propoxyphene Calibrators, EasyRA Propoxyphene QC Material
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JXN | Class II | 21 CFR 862.3700
Propoxyphene test system | 91 |
| DLJ | Class II | 21 CFR 862.3200 Clinical
toxicology calibrator | 91 |
| LAS | Class I (reserved) | 21 CFR 862.3280 Clinical
toxicology control material | 91 |
H. Intended Use:
1. Intended use(s):
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See indications for use below.
2. **Indication(s) for use:**
The EasyRA Propoxyphene (PPX) reagent is intended for the qualitative and semi-quantitative measurement of Propoxyphene in human urine, using MEDICA’s EasyRA Chemistry Analyzer in clinical laboratories. The cut-off point is 300ng/ml, and the assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) or Liquid Chromatography/mass spectrometry (LC/MS) are the preferred confirmatory method.
**The semi-quantitative mode is intended to enable laboratories to determine the appropriate dilution of the specimen for confirmation by a reference method such as GCMS or LC/MS and to allow laboratories to establish effective quality control procedures for the PPX assay.**
Medica’s Propoxyphene (PPX) Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica’s PPX reagent on the EasyRA clinical chemistry analyzer.
Medica’s Propoxyphene (PPX) QC Materials are intended for the validation of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica’s PPX reagent and PPX calibrator on the EasyRA clinical chemistry analyzer.
3. **Special conditions for use statement(s):**
For prescription use only
4. **Special instrument requirements:**
Medica EasyRA analyzer
I. **Device Description:**
The reagents are liquid ready to use. R1 contains a monoclonal anti-propoxyphene mouse antibody, glucose-6-phosphate (G6P), Nicotinamide adenine dinucleotide (NAD), stabilizers and preservatives. R2 contains Propoxyphene-labeled glucose-6-phosphate dehydrogenase (G6PDH), stabilizers and preservatives.
Controls and calibrators are human urine based, liquid ready to use, spiked with various concentrations of propoxyphene.
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J. Substantial Equivalence Information:
1. Predicate device name(s):
Lin-Zhi International, Inc. Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay
Lin-Zhi International, Inc. Propoxyphene Calibrators
Lin-Zhi International, Inc. Propoxyphene Controls
2. Predicate 510(k) number(s):
k033885, k023316
3. Comparison with predicate:
| Reagent Similarities and Differences | | |
| --- | --- | --- |
| Item | Submitted device: Easy RA PPX Reagent | Predicate Device: Propoxyphene reagent |
| Intended Use and indications for use | The Propoxyphene Enzyme Immunoassay is intended for the qualitative and semi-quantitative measurement of Propoxyphene, a pain-relieving drug, in human urine, using the EasyRA clinical chemistry analyzer. | Same |
| Sample type | Urine | Urine |
| Wavelength | 340 nm | 340 nm |
| Reaction type | Enzymatic Immunoassay | Enzymatic Immunoassay |
| Reagent storage | 2 – 8 °C | 2 – 8 °C |
| Test Methodology | The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. | The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. |
| Reagent Similarities and Differences | | |
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| Item | Submitted device: Easy RA PPX Calibrator and Control | Predicate Device: |
| --- | --- | --- |
| Intended Use | The propoxyphene Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to quantitate propoxyphene in human urine, using Medica's PPX reagent on the EasyRA chemistry analyzer. The Propoxyphene QC controls are intended for the validation of the PPX Enzymatic Immunoassay to determine Propoxyphene in human urine, using Medica's PPX reagent on the EasyRA chemistry analyzer. | Same |
| Matrix | Urine | Urine |
| Reagent storage | 2 – 8 °C | 2 – 8 °C |
# K. Standard/Guidance Document Referenced (if applicable):
None were referenced.
# L. Test Principle:
The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of mouse antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity.
In the absence of drug in the sample, propoxyphene-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody will bind to free drug, and the unbound propoxyphene-labeled G6PDH then exhibits its maximal enzyme activity.
# M. Performance Characteristics (if/when applicable):
# 1. Analytical performance:
# a. Precision/Reproducibility:
Within-run and total precision were performed by analyzing nine levels of urine samples spiked with propoxyphene to 75, 150, 225, 300, 375, 450, 525, and $600\mathrm{ng / mL}$ on a Medica EasyRA analyzer. Full calibration with five level calibrators was performed to generate calibration curves for the semiquantitative samples. The same samples were tested qualitatively using a one level $(300\mathrm{ng / mL})$ calibrator. Each sample was tested twice each morning and twice each afternoon for 20 days. The results are summarized below.
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Qualitative
| Target conc. (ng/ml) | 0 | 75 | 150 | 225 | 300 | 375 | 450 | 525 | 600 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pos/Neg | 0/80 | 0/80 | 0/80 | 0/80 | 1/79 | 80/0 | 80/0 | 80/0 | 80/0 |
Semi-quantitative
| Target conc. (ng/ml) | 0 | 75 | 150 | 225 | 300 | 375 | 450 | 525 | 600 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pos/Neg | 0/80 | 0/80 | 0/80 | 0/80 | 20/60 | 80/0 | 80/0 | 80/0 | 80/0 |
| Within run %CV | N/A | 5.10 | 2.44 | 1.38 | 1.65 | 1.45 | 1.69 | 1.65 | 2.60 |
| Total %CV | N/A | 5.80 | 2.86 | 2.22 | 2.16 | 2.13 | 2.16 | 2.37 | 3.45 |
b. Linearity/assay reportable range:
Recovery was evaluated by testing nine urine samples spiked with propoxyphene to concentrations ranging from 50 to 800 ng/mL. Each sample was tested n=10 and the average value was calculated and compared to the actual value of the spiked sample. The results are summarized below.
| | Sample # 1 | Sample # 2 | Sample # 3 | Sample # 4 | Sample # 5 | Sample # 6 | Sample # 7 | Sample # 8 | Sample # 9 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Target conc. | 50ng/ml | 100ng/ml | 150ng/ml | 200ng/ml | 300ng/ml | 400ng/ml | 500ng/ml | 600ng/ml | 800ng/ml |
| Mean | 56.3 | 98.0 | 143.8 | 210.1 | 324.6 | 429.7 | 522.8 | 633.0 | 868.2 |
| SD | 5.6 | 3.6 | 4.3 | 3.5 | 4.4 | 13.7 | 16.8 | 28.2 | 63.2 |
| CV | 10.0 | 3.7 | 3.0 | 1.7 | 1.3 | 3.2 | 3.2 | 4.5 | 7.3 |
| % Recovery | 112.6% | 98.0% | 95.9% | 105.1% | 108.2% | 107.4% | 104.6% | 105.5% | 108.5% |
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Calibrators and controls were previously cleared under k023316. Medica is re-labeling these products for use on the EasyRA analyzer and verifying the calibrator and control values of the previously cleared products on the EasyRA analyzer to ensure traceability of the calibrators and controls.
Accelerated and real time stability studies were performed and support Medica's labeled storage conditions and expiration dating.
d. Detection limit:
Performance at low drug concentrations in the semi-quantitative assay was
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characterized by determination of recovery (see section b above).
# e. Analytical specificity:
Medica performed two interference studies for the PPX assay. The first coved interference from ten endogenous substances. The second investigated the potential cross-reactivity of thirty drugs with the PPX reagent.
# Interference from urine endogenous substances:
Ten endogenous substances, seven pH levels, and seven specific gravity levels were evaluated as potential interferants of the propoxyphene (PPX) semi-Quantitative Assay on the EasyRA analyzer. Medica evaluated the potential interference at urine propoxyphene levels of $150\mathrm{ng / ml}$ , $300\mathrm{ng / ml}$ , and $450\mathrm{ng / ml}$ . The pH and specific gravity interference was evaluated in urine samples containing $225\mathrm{ng / ml}$ , $300\mathrm{ng / ml}$ , and $375\mathrm{ng / ml}$ propoxyphene. The following substances did not demonstrate significant interferences at the concentrations shown.
| Substance | Concentration Tested without significant interference |
| --- | --- |
| Ascorbic Acid | 2.5 mg/dl |
| Creatinine | 500 mg/dl |
| Glucose | 1200 mg/dl |
| Hemoglobin | 100 mg/dl |
| Albumin (HSA) | 300 mg/dl |
| Oxalic Acid | 0.5 mg/dl |
| Sodium Chloride | 2300 mg/dl |
| Acetone | 790 mg/dl |
| Ethanol | 790 mg/dl |
The pH interference testing showed not significant interference due to pH ranging from 4.5 to 8.0.
The specific gravity interference testing showed not significant interference due to specific gravities ranging from 1.005 to 1.031.
# Interference from cross reactivity
Thirty substances were evaluated as potential interferants of the propoxyphene (PPX) assay on the EasyRA analyzer.
The following compounds had a cross reactivity of less than $0.01\%$ when spiked into propoxyphene free urine and urine with propoxyphene levels of 225 and $375~\mathrm{ng / mL}$ : Amitriptyline, Amphetamine, Bupropion, Ecgonine, Ephedrine, Codeine, Caffeine, Chlorpheniramine, Cocaine, Lidocaine,
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Ranitidine, Meperidine, Valproic Acid, Methaqualonel, Nortriptyline, Phenobarbital, Imipramine, Promethazine, Acetaminophen, Chlorpromazine, Dextromethorphan, Acetylsalicylic acid, Benzoylecgonine, Methadone, Methamphetamine, Morphine, Oxazepam, PCP, Secobarbital.
Nor-propoxyphene cross reactivity is summarized below.
| Substance | Nominal PPX value 0.0ng/ml | | |
| --- | --- | --- | --- |
| | True PPX (ng/ml) | Read PPX (ng/ml) | % Cross Reactivity |
| Norproxyphene 620 ng/ml | 0 | 279 | 45.06% |
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, 1.a, above.
2. Comparison studies:
a. Method comparison with predicate device:
For the method comparison study, human urine samples with LC/MS propoxyphene and norpropoxyphene values were obtained from a reference laboratory. The samples were tested using the EasyRA propoxyphene assay in both qualitative and semi-quantitative modes of operation and compared to the GC/MS results. The results are summarized below.
Semi-quantitative mode
| | Low Neg by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) | Percent Agreement with LC/MS |
| --- | --- | --- | --- | --- | --- |
| Pos | 0 | 1 | 11 | 45 | 95% |
| Neg | 54 | 7 | 0 | 0 | 100% |
Qualitative results
| | Low Neg by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and | Near Cutoff Positive by LC/MS (Between cutoff and | High Positive by LC/MS (greater than +50%) | Percent Agreement with LC/MS |
| --- | --- | --- | --- | --- | --- |
| | | cutoff) | +50%) | | |
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8
| | | cutoff) | +50%) | | |
| --- | --- | --- | --- | --- | --- |
| Pos | 0 | 1 | 11 | 45 | 95% |
| Neg | 54 | 7 | 0 | 0 | 100% |
Discrepant Sample Results
| Total LC/MS Value (ng/ml) | EasyRA Semi-Quantitative | EasyRA Qualitative |
| --- | --- | --- |
| 220 | POS | POS |
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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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
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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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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.
