The Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum. The Vacu Lab Gel & Clot Activator Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator and a barrier gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
Device Story
Teco Blood Specimen Collection Devices consist of sterile, evacuated plastic tubes used for venous blood collection. The Vacu Lab Plain Tube contains a silica clot activator and silicone surfactant coating; the Vacu Lab Gel & Clot Activator Tube adds a barrier gel. Used in clinical settings by healthcare personnel to collect and transport blood samples. Following collection, tubes are centrifuged to separate serum from cellular components. The resulting serum is used for various clinical chemistry assays. The closed system design facilitates safe handling and processing. The device benefits patients by providing a standardized, stable medium for serum-based diagnostic testing, ensuring sample integrity for laboratory analysis.
Clinical Evidence
Bench testing only. Method comparison study performed comparing subject tubes to predicate using blood samples analyzed for 27 clinical chemistry analytes (e.g., total protein, albumin, electrolytes, enzymes, hormones). Linear regression analysis demonstrated r² ≥ 0.95 for all analytes, meeting acceptance criteria.
Technological Characteristics
Sterile, plastic, evacuated tubes. Components: closure assembly, silica clot activator, silicone surfactant coating, inert polyester barrier gel (Gel tube only). Radiation sterilization per ANSI/AAMI/ISO 11137. Compliant with CLSI H18-A, H1-A5, and H3-A5 standards.
Indications for Use
Indicated for the collection, transport, separation, and processing of venous blood in a closed system for clinical laboratory assays requiring serum specimens. Intended for use by healthcare professionals in clinical settings.
Regulatory Classification
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k060364
B. Purpose for Submission:
New device
C. Measurand:
Not applicable (devices may be used to collect blood samples for many different assays)
D. Type of Test:
Not applicable
E. Applicant:
Teco Diagnostics
F. Proprietary and Established Names:
Teco Diagnostics Vacu Lab Plain Tube
Teco Diagnostics Vacu Lab Gel and Clot Activator Tube
G. Regulatory Information:
1. Regulation section:
21 CFR 862.1675
2. Classification:
Class II
3. Product code:
JKA
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4. Panel:
75 (Clinical Chemistry)
H. Intended Use:
1. Intended use(s):
The Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
The Vacu Lab Gel & Clot Activator Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator and a barrier gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
2. Indication(s) for use:
Refer to intended use above
3. Special conditions for use statement(s):
Prescription Use only.
These blood collection tubes are not intended to be used to collect blood specimens for therapeutic drug monitoring.
4. Special instrument requirements:
Not applicable
I. Device Description:
The Teco Diagnostics Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube. It consists of a closure assembly, a silica clot activator, and a silicone surfactant coated on the inside of the plastic tube. The Teco Diagnostics Vacu Lab Gel and Clot Activator Tube is identical to the Plain Tube except for the addition of a barrier gel that separates the serum from the cells when centrifuged.
J. Substantial Equivalence Information:
1. Predicate device name(s):
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BD Vacutainer Plus SST Serum Separator Tube
2. Predicate 510(k) number(s):
k023075
3. Comparison with predicate:
| Similarities | | | |
| --- | --- | --- | --- |
| Item | Plain Tube | Gel Separator Tube | Predicate |
| Components | Same, except no gel barrier | Same | closure assembly, inert polyester gel barrier, silica clot activator, silicone surfactant coated plastic tube |
| Matrix | Same | Same | Serum |
| Analytes | Same | Same | General Clinical Chemistry Analytes |
| Differences | | | |
| --- | --- | --- | --- |
| Item | Plain Tube | Gel Separator Tube | Predicate |
| Therapeutic Drug Monitoring (TDM) | Not intended for use with TDM samples | Not intended for use with TDM samples | May be used for TDM samples |
## K. Standard/Guidance Document Referenced (if applicable):
CLSI (formerly NCCLS) H18-A: Procedures for the Handling and Processing of Blood Specimens; Approved Guideline
CLSI (formerly NCCLS) H1-A5: Evacuated Tubes and Additives for Blood Specimen Collection, Approved Standard – Fifth Edition
CLSI (formerly NCCLS) H3-A5: Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture, Approved Standard – Fifth Edition
ANSI/AAMI/ISO 11137: Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
## L. Test Principle:
Not applicable.
## 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):
Not applicable.
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:
To demonstrate comparable performance with the predicate device, the sponsor collected blood samples into the Plain Tube, the Gel and Clot Activator Tube, and the predicate tube. The specimens were allowed to clot, and the serum was removed for testing immediately after centrifugation. Serum from the three tubes was then tested on two different analyzers for total protein, albumin, total bilirubin, direct bilirubin, AST, ALT, ALP, r-GT, cholesterol, potassium, glucose, creatinine, calcium, chloride, creatine kinase, hCG, magnesium, phosphorous, triglyceride, uric acid, BUN, sodium, CK-MB, TSH, free T4, ferritin, and prolactin. The sponsor's acceptance criterion was that the $r^2$ value from linear regression be $\geq 0.95$. Linear regression was performed using the predicate (independent variable) vs. the Plain Tube (dependent variable) and the predicate (independent variable) vs. the Gel and Clot Activator Tube (dependent variable). All of the comparisons met the acceptance criteria.
b. Matrix comparison:
Not applicable. These blood collection tubes are for serum only.
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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):
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.
