UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the Sysmex® UF-1000i™ Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak. The list of assayed parameters includes: Sysmex UF-1000i:RBC(/μL), WBC//μL), Epithelial (/uL), Cast, Bacteria (/μL), Crystals, Conductivity (mS/cm) Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
Device Story
UA-Cellular Complete is a tri-level, in vitro diagnostic control material; contains stabilized human-source red/white blood cells, stabilized bacteria, and simulated urine sediments in a preservative medium. Used by clinical laboratory personnel to verify performance (calibration, precision, accuracy) of Sysmex UF-1000i and Siemens Clinitek Atlas analyzers prior to patient testing. Provides values within expected ranges for chemistry and cellular parameters; ensures instrument alignment. Packaged in 4 oz. amber plastic bottles. Human source materials tested non-reactive for HBsAg, HIV, HCV, and syphilis.
Clinical Evidence
No clinical data. Analytical performance verified via value assignment studies across three external sites and internal testing. Precision and stability (shelf-life and open-vial) verified using real-time studies on the Sysmex UF-1000i and Siemens Clinitek Atlas platforms. Assay data met ±3 Standard Deviation requirements.
Technological Characteristics
Tri-level liquid control; contains stabilized human-source RBCs, WBCs, bacteria, and simulated sediments. Preservative medium. Packaged in 4 oz. amber plastic bottles. Storage 2-10°C. Open-vial stability 30 days; shelf-life 60 days. Standard referenced: CLSI EP05-A2.
Indications for Use
Indicated for use as an assayed chemistry and cellular urine control to evaluate accuracy and precision of automated urinalysis procedures on Sysmex UF-1000i and Siemens Clinitek Atlas analyzers. Intended for clinical laboratory use.
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
MAS UA Control (k023928)
UFII Control (k080887)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k131444
B. Purpose for Submission:
New device
C. Measurand:
Quality control material for the following parameters in urine samples: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, color and microscopic determination of RBC, WBC, epithelial cells, casts, bacteria, crystals, and conductivity.
D. Type of Test:
Not applicable
E. Applicant:
Streck
F. Proprietary and Established Names:
UA-Cellular Complete
G. Regulatory Information:
1. Regulation section:
862.1660, Quality control material, (assayed, and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJW
4. Panel:
Chemistry (75)
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H. Intended Use:
1. Intended use(s):
See indications for use statements below.
2. Indication(s) for use:
UA-Cellular Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the Sysmex® UF-1000i™ Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak.
The list of assayed parameters includes:
Sysmex UF-1000i: RBC(/μL), WBC(/μL), Epithelial (/μL), Cast, Bacteria (/μL), Crystals, Conductivity (mS/cm)
Siemens Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Sysmex® UF-1000i™ Automated Urine Particle Analyzer
Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer
I. Device Description:
UA-Cellular Complete is an in vitro diagnostic product designed specifically for use with the Siemens Clinitek Atlas Automated Urine Chemistry Analyzer using the Clinitek Atlas 10 Reagent Pak and the Sysmex UF-1000i Automated Urine Particle Analyzer. UA-Cellular Complete is a tri-level control material which contains the following: stabilized mammalian red blood cells (human source) and white blood cells, stabilized bacteria, and simulated urine sediments in a preservative medium. Analyte levels are adjusted with appropriate chemicals. The product is packaged in 4 oz. amber plastic bottles with foil-lined flip-top-caps. All human source material used to manufacture this product was non-reactive for antigens to Hepatitis B (HBsAg), negative by tests for antibodies to HIV (HIV-1/HIV-s) and Hepatitis C (HCV), non-reactive for HIV-1 RNA and HCV RNA by licensed NAT, and non-reactive to Serological Test for Syphilis (STS) using techniques specified by the U.S. Food and Drug Administration.
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J. Substantial Equivalence Information:
1. Predicate device name(s):
MAS UA Control
Sysmex UF-1000i with Urinalysis WAM
2. Predicate 510(k) number(s):
k023928
k080887
3. Comparison with predicate:
| Similarities and Differences | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate 1 (k023928 – MAS UA Control) | Predicate 2 (k080887 – UFII Control) |
| Intended Use | Same | Same | Assayed control material for evaluating the accuracy and precision of automated procedures that measure urinary analytes |
| Measurands | Sysmex UF-1000i: RBC, WBC, Epithelial, Cast, Bacteria, Crystals, Conductivity
Siemens Clinitek Atlas with Atlas 10
Reagent Pak: Glucose Bilirubin, Ketones, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes, Color, Clarity | Glucose; Bilirubin,Ketones, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte, Creatinine, Color, Appearance, Crystals | RBC, WBC, Epithelial Cells, Cast, Bacteria, Conductivity |
| Open-Vial Stability | 30 days | 6 weeks at 18-25°C
3 months at 2-8°C | 30 days |
| Closed-Vial Stability | 60 days | 2 years | 6 months |
| Reagents | Stabilized mammalian red blood cells and white blood cells, stabilized | UA Control is a liquid stable control material prepared from human urine. Analyte levels | Latex Control Particles |
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| Similarities and Differences | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate 1 (k023928 – MAS UA Control) | Predicate 2 (k080887 – UFII Control) |
| | bacteria, and simulate urine sediments in a preservative medium. Analyte levels are adjusted with appropriate chemicals. | are adjusted with various pure chemicals and human source materials. UA Control also contains preservatives and stabilizers. | |
| Storage Conditions | 2-10°C | 2-8°C | 2-10°C |
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
L. Test Principle:
UA-Cellular Complete is intended to be run by the clinical laboratory to collectively verify the performance attributes (i.e. calibration, precision and accuracy) of the intended instrument platforms, prior to running clinical patient specimens. The comprehensive tri-level UA-Cellular Complete control serves to align six stabilized urine particle types (i.e. red blood cells, white blood cells, cast, crystals, bacteria and epithelial) with the ten urine chemistry parameters.
Level 1-PC Control – Serves as the positive chemistry control for the urine chemistry parameters that do not align with a corresponding urine particle type (i.e. glucose, bilirubin, ketones and urobilinogen).
Level 1-PCM Control – Serves as the positive chemistry control for the urine chemistry parameters that serve to align with a corresponding urine particle type.
Level NC Control – Serves as the true “negative” control for all qualitative and semi-qualitative urine chemistry measurands and the quantitative urine particle types.
UA-Cellular Complete provides values within the expected ranges indicated on the assay sheet.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
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a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Value assignment:
Value Assignment for the UA-Cellular® Complete parameters was based on data collected across three external sites and data collected internally at Streck. Data was collected across three separately manufactured lots. Each site involved in testing provided a 10-run reproducibility study for the tri-level control on each lot (n=40 per level). Four instruments of the Siemens® Clinitek Atlas and Sysmex® UF-1000i™ were utilized to collect data. Four operators were used in the value assignment study. Assay data collected met the sponsor’s ±3 Standard Deviation requirements.
Stability:
Shelf-Life and Open Vial Stability testing protocols and acceptance criteria were described and found to be adequate.
Shelf-Life – The 60-day claim was verified in real-time stability studies on the Sysmex® UF-1000i™ and Siemens® Clinitek Atlas with all three lots of device.
Open-vial – The open-vial stability claim was verified on both the Sysmex® UF-1000i™ Automated Urine Particle Analyzer and the Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer using the Clinitek Atlas 10 Reagent Pak.
Open-vial stability testing was performed real-time and is 30 days.
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable
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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:
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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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.
