K182781 · Polymer Technology Systems, Inc. D/B/A Pts Diagnostics · CGA · Dec 21, 2018 · Clinical Chemistry
Device Facts
Record ID
K182781
Device Name
PTS Professional Chemistry Kit
Applicant
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Product Code
CGA · Clinical Chemistry
Decision Date
Dec 21, 2018
Decision
SESK
Submission Type
Traditional
Regulation
21 CFR 862.1345
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The PTS Professional Chemistry Kit is a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in capillary (fingerstick) or venous whole blood. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The HbA1C test provides quantitative measurement of the percent of glycated hemoglobin levels. The test is for professional use to monitor glycemic control in people with diabetes.
Device Story
Convenience kit combining previously cleared CardioChek PA, CardioChek Plus, and A1CNow+ analyzers; intended for professional use. Input: capillary or venous whole blood samples. Operation: enzymatic reflectance photometry (glucose, cholesterol, HDL, triglycerides) or electrochemical/immunoassay (HbA1c). Analyzers process samples via test strips and MEMo chips; results displayed on screen. Data transfer via PTS Connect Dock/ProLink to computer systems; printing via CardioChek Printer. Output: quantitative analyte concentrations. Clinical utility: monitoring glycemic control and diagnosing lipid/metabolic disorders. Benefits: consolidated testing workflow for point-of-care professional settings.
Clinical Evidence
No clinical data; bench testing only. Performance characteristics (precision, linearity, limit of detection, analytical specificity, method comparison) were previously established in predicate submissions (K140068, K090413, K151545, K162282, K071507, K041750, K014099).
Technological Characteristics
Convenience kit containing reflectance/electrochemical test strips, MEMo chips, and analyzers. Analyzers use optical reflectance or electrochemical sensing. Connectivity via proprietary dock/link for data transfer. Single-use components. No new technological characteristics introduced.
Indications for Use
Indicated for professional use to quantitatively measure %HbA1c, total cholesterol, HDL, triglycerides, and glucose in capillary or venous whole blood for patients with diabetes, lipid metabolism disorders, atherosclerosis, liver/renal disease, or carbohydrate metabolism disorders. Not for diabetes screening.
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
CardioChek® Plus Test System (k140068)
A1CNow®+ (k090413)
Reference Devices
k162282
k151545
k071507
k041750
k014099
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k182781
B. Purpose for Submission:
Combination of previously cleared test systems into a convenience kit
C. Measurand:
Hemoglobin A1c, glucose, triglycerides, high density lipoprotein, cholesterol
D. Type of Test:
Convenience Kit
E. Applicant:
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
F. Proprietary and Established Names:
PTS Professional Chemistry Kit
G. Regulatory Information:
1. Regulation section:
| Regulation Section | Classification | Product Code | Panel |
| --- | --- | --- | --- |
| Glycosylated Hemoglobin Assay (21 CFR 864.7470) | Class II | LCP | Hematology (81) |
| Glucose Test System (21 CFR 862.1345) | Class II | CGA | Chemistry (75) |
| Cholesterol (Total) Test System (21 CFR 862.1175) | Class I, meets the limitation of exemption 21 CFR 862.9(c)(4) | CHH | |
| Lipoprotein Test System (21 CFR 862.1475) | Class I, meets the limitation of exemption 21 CFR 862.9(c)(4) | LBR | |
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| Regulation Section | Classification | Product Code | Panel |
| --- | --- | --- | --- |
| Triglyceride Test System (21 CFR 862.1705) | Class I, meets the limitation of exemption 21 CFR 862.9(c)(4) | JGY | |
H. Intended Use:
1. Intended use(s):
See Indications for use.
2. Indication(s) for use:
The PTS Professional Chemistry Kit is a medical device convenience kit that quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in capillary (fingerstick) or venous whole blood.
- Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
- HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
- Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- The HbA1C test provides quantitative measurement of the percent of glycated hemoglobin levels. The test is for professional use to monitor glycemic control in people with diabetes.
3. Special conditions for use statement(s):
For prescription use only.
For in vitro diagnostic use only.
The Glucose and HbA1c test systems in this kit are not intended for use in screening for diabetes.
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4. Special instrument requirements:
This convenience kit may include up to three different analyzers, the Cardiochek PA, the Cardiochek Plus and the A1cNow analyzer. Users should follow the instructions on each test strip package insert to determine which analyzer is appropriate for use with that strip.
I. Device Description:
The PTS Professional Chemistry Kit combines the previously cleared test systems listed below:
The CardioChek® PA test system that consists of the CardioChek® PA Analyzer and certain PTS Panels® Test Strips.
The CardioChek® Plus test system that consists of the CardioChek® Plus Analyzer and certain PTS Panels® Test Strips.
The PTS Panels® Test Strips consist of varying amounts of test strips packed into a vial and a lot-specific MEMo® Chip. The PTS Panels® Test Strips for use with this kit include: PTS Panels® Lipid Panel Test Strips, PTS Panels® Chol+HDL+Glu Test Strips, PTS Panels® Chol+Glu Test Strips, PTS Panels® eGlu Test Strips and PTS Panel® Glucose Test Strips. The PTS Panels® Test Strips are single-use.
PTS Panels® Controls contain two vials of control solution that have two levels of each analyte. Controls included in this kit are the PTS Panels® HDL Cholesterol Controls and PTS Panels® Multi-Chemistry Controls.
The PTS Collect™ Capillary Tubes are a glass and plastic tube capable of dispensing an exact volume of blood from the capillary tube to a test strip.
A1CNow®+ consists of three components: a semi-disposable plastic-encased device (the analyzer), a plastic cartridge enclosing dry reagent strips, and a shaker kit.
The Unistik® 3 Pre-set Single Use Safety Lancets are sterile, single-use, auto-disabling lancets to perform finger sticks to obtain capillary blood.
The PTS Connect™ Dock and PTS Connect® ProLink are included to transfer data from the CardioChek® Plus Analyzer, CardioChek® PA Analyzer, and the A1CNow®+ to computer systems. The CardioChek® Printer interfaces with the CardioChek® Plus and CardioChek® PA Analyzer to print results onto paper and self-adhesive labels.
The PTS Professional Chemistry Kit contents are customizable according to user needs. Individual kits may not contain all of the devices described in this submission.
J. Substantial Equivalence Information:
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1. Predicate device name(s) and 510(k) numbers:
CardioChek® Plus Test System (k140068)
A1CNow®+ (k090413)
2. Comparison with predicate:
| Similarity | | | |
| --- | --- | --- | --- |
| Item | PTS Professional Chemistry Kit (Candidate Device) | CardioChek® Plus Analyzer (k140068) | A1CNow®+ (k090413) |
| Intended Use | Quantitatively measures the percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in whole blood. | Quantitatively measures total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose in whole blood. | Quantitatively measures the percent of glycated hemoglobin (%Alc) in whole blood |
| Difference | | | |
| Analyte | Percent of glycated hemoglobin (%Alc), total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose | Total cholesterol, high density lipoprotein (HDL), triglycerides, and glucose | Percent of glycated hemoglobin (%Alc), |
## K. Standard/Guidance Document Referenced (if applicable):
None referenced.
## L. Test Principle:
PTS Panels® Test Strips include reflectance and electrochemical test strips. The reflectance assays include quantitative determination of glucose, total cholesterol, HDL cholesterol and triglycerides. The test strips utilize enzymatic methods on a dry strip that is read by reflectance photometry. A single application of whole blood flows laterally to dose each set of analyte specific membranes once the blood is applied to the test strip. The red blood cells are separated by the test strip such that only the serum or plasma reaches the reaction membranes. The color resulting from the enzymatic reaction is read by the analyzers by reflectance. The reflectance is compared to the calibration curve stored in the memory chip
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and converted into concentration and displayed by the analyzer.
PTS Panels eGLU glucose test strips use electrochemical (amperometric) technology to produce a glucose result. When the blood is applied to the test strip, the blood starts a chemical reaction that produces an electrical current. The current is converted into a glucose result and is displayed on the analyzer screen.
The A1CNow+ analyzer utilizes both immunoassay and chemistry technology to measure A1C and total hemoglobin, respectively. Upon the addition of a diluted blood sample, blue microparticles conjugated to anti-A1C antibodies migrate along the reagent strips. The amount of blue microparticles captured on the strips reflects the amount of A1C in the sample. For the total hemoglobin (Hb) portion of the test, the sample diluent converts Hb to met-Hb. The intensity of met-Hb color measured on the reagent strips is proportional to the concentration of hemoglobin in the sample. Test results are expressed as % A1C (A1C ÷ total Hb x 100).
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
All devices included in this kit are previously cleared and are being combined into a kit without modification.
a. Precision/Reproducibility:
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
b. Linearity/assay reportable range:
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
d. Detection limit:
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
e. Analytical specificity:
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
f. Assay cut-off:
Not applicable.
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2. Comparison studies:
a. Method comparison with predicate device:
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
b. Matrix comparison:
Not applicable. Appropriate sample types previously established for the test systems in this kit.
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):
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
The sponsor referenced information in k162282, k151545, k140068, k090413, k071507, k041750 and k014099.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.
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.
