The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is “For In Vitro Diagnostic Use Only”.
Device Story
Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set consists of two sets of five-level lyophilized aqueous buffer vials. Set 1 contains Phosphorous, Urea Nitrogen, Uric Acid; Set 2 contains Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. Levels A-E are related by linear dilution. Used in clinical laboratories to monitor analytical performance of chemistry analyzers; provides target concentration values for quality control. Healthcare providers use these values to establish laboratory-specific means and acceptable ranges for assay monitoring. Benefits include detection of systematic analytical deviations, ensuring accuracy of patient test results.
Clinical Evidence
No clinical data. Performance is supported by bench testing, specifically stability studies. Reconstituted stability is 72 hours for Set 1 and 10 days for Set 2 at 2-8°C. Shelf life is one year at 2-8°C.
Technological Characteristics
Lyophilized aqueous buffer-based quality control material. Two sets of five levels each. Analytes: Phosphorous, Urea Nitrogen, Uric Acid (Set 1); Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin (Set 2). Storage: 2-8°C. Reconstituted stability: 72 hours (Set 1), 10 days (Set 2).
Indications for Use
Indicated for use as assayed quality control material for quantitative chemistry assays on specified analyzers to detect systematic analytical deviations. Not for calibration or standardization. Prescription use only.
Regulatory Classification
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Predicate Devices
Audit™ MicroCV™ General Chemistry Linearity Set (k042318)
Submission Summary (Full Text)
{0}
1
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k111964
B. Purpose for Submission:
New device
C. Measurand:
Quality control materials for Phosphorous, Urea Nitrogen, Uric Acid (in Set 1); Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin (in Set 2).
D. Type of Test:
Not applicable
E. Applicant:
Aalto Scientific, Ltd.
F. Proprietary and Established Names:
Audit MicroCV™ Urine/Fluids Chemistry Linearity Set
G. Regulatory Information:
1. Regulation section:
21CFR 862.1660, Quality Control Material
2. Classification:
Class I, reserved
3. Product code:
JJY, multi-analyte controls, all kinds
4. Panel:
{1}
Clinical Chemistry (75)
## H. Intended Use:
1. Intended use(s):
See indications for use below
2. Indication(s) for use:
The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is “For In Vitro Diagnostic Use Only”.
3. Special conditions for use statement(s):
For prescription use only.
The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set should not be used for calibration or standardization of the assays for Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, Phosphorous, Urea Nitrogen, Uric Acid.
4. Special instrument requirements:
Performance was established on the Roche P-Modular analyzer.
## I. Device Description:
The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is a two-set ten-vial lyophilized quality control material with Set 1 containing Phosphorous, Urea Nitrogen, Uric Acid and Set 2 containing Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin. Each set has five levels (Levels A through E, each level packaged into a 2-ml vial). Level A contains the indicated analytes at concentrations near the lower limit level. Level E contains the indicated analytes at concentrations near the upper
{2}
limit level of chemistry analyzers. Levels B-D are related by linear dilution of Level A and Level E.
All human source materials used to produce this product have been tested for HbsAg, anti-HCV, HIV-1 and HIV-2 and found to be non-reactive by FDA cleared/approved tests.
# J. Substantial Equivalence Information:
1. Predicate device name(s):
The Audit™ MicroCV™ General Chemistry Linearity Set
2. Predicate K number(s):
k042318
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate device | Predicate device (k042318) |
| Indications for Use | Same | Device is assayed quality control materials intended to detect systematic analytical deviations of laboratory testing procedures. |
| Number of levels per set | Same | 5 |
| Form | Same | Lyophilized |
| Differences | | | |
| --- | --- | --- | --- |
| Item | Device | | Predicate |
| Number of Analytes per vial | Set 1 | Set 2 | 30 |
| | 3 | 10 | |
| Matrix | Aqueous buffer | | Human based Serum |
| Kit Contents | 10 x 2 mL | | 5 x 5 ml |
| Storage | 2 – 8 °C for 12 months | | 2 – 8 °C for 1 year |
| Open Bottle Stability | 3 days for Set 1, 10 days for Set 2 at 2 – 8 °C | | 1 day at 2 – 8 °C |
| Analytes | Phosphorous, Urea Nitrogen, Uric Acid (Set 1); Amylase, Calcium, Glucose, | | Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin |
{3}
4
| | Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin (Set 2). | (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2, Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Lactate, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid |
| --- | --- | --- |
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP6-A: evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
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 and value assignment
All components used for the Audit™ Micro CV™ Urine/Fluids Chemistry Linearity Set are obtained from commercial vendors and are inspected in-house.
For each analyte, value assignment for Level A through Level E is performed on one instrument (Roche P-Modular) by one set of reagent. Each analyte was measured 15 times (15 separate vials) and the mean value of each analyte was used to establish target concentration values listed on the insert at each level. The target ranges listed on the package insert were calculated as $\pm 15\%$ of the observed value. The results on Roche P-modular are shown in the table below:
{4}
| Assay/Reagent | Units | A | | B | | C | | D | | E | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | Range | Mean | Range | Mean | Range | Mean | Range | Mean | Range |
| BUN | mg/dL | 34.8 | 29.5-40.0 | 859.9 | 730.9-988.8 | 1663.4 | 1413.9-1912.9 | 2448.5 | 2081.2-2815.8 | 3218.5 | 2735.7-3701.3 |
| Phosphorus | mg/dL | 10.7 | 9.1-12.4 | 60.4 | 51.3-69.4 | 109.0 | 92.7-125.4 | 153.7 | 130.7-176.8 | 200.1 | 170.1-230.1 |
| Uric Acid | mg/dL | 4.41 | 3.70-8.07 | 31.86 | 27.10-36.64 | 54.03 | 45.90-62.14 | 74.06 | 63.00-85.17 | 94.55 | 80.40-108.73 |
| Amylase | mg/dL | 10 | 9-12 | 366 | 311-421 | 714 | 607-821 | 1057 | 899-1216 | 1378 | 1171-1585 |
| Calcium | mg/dL | 2.15 | 1.83-2.47 | 12.22 | 10.39-14.05 | 22.35 | 19.00-25.71 | 32.28 | 27.44-37.12 | 41.56 | 35.33-47.79 |
| Creatinine | mg/dL | 8.23 | 7.00-9.47 | 153.38 | 130.38-176.39 | 297.11 | 252.54-341.68 | 439.86 | 373.88-505.84 | 575.12 | 488.85-661.39 |
| Glucose | mg/dL | 8 | 7-9 | 169 | 144-194 | 329 | 279-378 | 492 | 418-565 | 648 | 551-745 |
| Magnesium | mg/dL | 2.65 | 2.25-3.05 | 7.64 | 6.49-8.78 | 12.47 | 10.60-14.34 | 17.55 | 14.92-20.18 | 22.34 | 18.89-25.69 |
| Sodium | mEq/L | 27.6 | 23.5-31.7 | 72.4 | 61.6-83.3 | 119.2 | 101.4-137.1 | 166.8 | 141.8-191.8 | 211.9 | 180.1-243.7 |
| Potassium | mEq/L | 2.23 | 1.89-2.56 | 25.50 | 21.68-29.33 | 48.72 | 41.41-56.03 | 70.27 | 59.73-80.81 | 87.98 | 74.78-101.17 |
| Chloride | mEq/L | 19.6 | 16.6-22.5 | 67.5 | 57.4-77.7 | 114.0 | 131.1-96.9 | 163.2 | 138.7-187.7 | 210.9 | 179.3-242.6 |
| Microprotein | mg/dL | 8.9 | 7.6-10.3 | 85.1 | 72.3-97.8 | 129.8 | 110.3-149.3 | 153.0 | 130.1-176.0 | 214.5 | 182.3-246.6 |
| Microalbumin | mg/dL | 5.3 | 4.5-6.1 | 9.7 | 8.2-11.1 | 13.7 | 11.7-15.8 | 18.5 | 21.2-15.7 | 24.5 | 20.9-28.2 |
## Stability
Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Accelerated stability was performed to predict the shelf-life and open-vial of the linearity sets. Real-time stability is ongoing to support the stability of the linearity sets. The sponsor states that the shelf-life of the linearity sets are 12 months when stored at $2 - 8^{\circ}\mathrm{C}$. The open-vial stability after reconstitution is 3 days for Set1 and 10 days for Set 2, respectively, at $2 - 8^{\circ}\mathrm{C}$.
## d. Detection limit:
Not applicable
## e. Analytical specificity:
{5}
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:
The expected values are provided in the labeling for each specific lot.
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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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.
