BK251300 · Grifols Diagnostic Solutions Inc. San Diego, CA 92127 · QTM · Mar 26, 2026 · Microbiology
Device Facts
Record ID
BK251300
Device Name
Procleix Plasmodium Quality Control
Applicant
Grifols Diagnostic Solutions Inc. San Diego, CA 92127
Product Code
QTM · Microbiology
Decision Date
Mar 26, 2026
Decision
SESE
Regulation
21 CFR 866.3920
Device Class
Class 2
Indications for Use
Procleix® Plasmodium Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Plasmodium falciparum with the Procleix Plasmodium Assay. This product is intended to be used solely with the Procleix Plasmodium Assay, a licensed donor screening assay performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device.
Device Story
Procleix Plasmodium Quality Control consists of single-use positive and negative control vials containing HEPES-buffered solutions (positive contains RNA transcript). Used as external assayed quality control material to monitor performance of Procleix Plasmodium Assay on Procleix Panther System. Laboratory personnel process control vials as samples to monitor day-to-day test variation, lot-to-lot performance, and operator variation. Output is signal-to-cutoff (S/CO) ratio; used by clinicians/lab staff to verify assay validity and identify random or systematic errors in nucleic acid testing procedures. Benefits include improved reliability of donor screening results.
Clinical Evidence
Bench testing only. Two reproducibility studies conducted: a multisite study (3 sites, 216 tests) and a single-site lot-to-lot reproducibility study (108 tests). Primary endpoints were S/CO variation (SD and %CV) across runs, days, instruments, operators, and reagent lots. Results showed low variability for the positive control (%CV < 10%). Negative control S/CO values were < 0.02, with high %CV attributed to low analyte signal.
Technological Characteristics
In vitro transcript-based quality control reagents. Composition: HEPES-buffered solution with detergent (negative) and RNA transcript (positive). Form factor: 1.2 mL single-use vials. Storage: -15°C to -35°C. Shelf life: 24 months. Used with Procleix Panther System for nucleic acid testing (reverse transcription, amplification, detection).
Indications for Use
Indicated for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Plasmodium falciparum in donor screening assays performed on the Procleix Panther System.
Regulatory Classification
Identification
An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.
Special Controls
An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."
*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
{0}
Grifols Diagnostic Solutions Inc.
10808 Willow Court.
San Diego, CA. 92127
USA
# GRIFOLS
## 510(K) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21CFR 807.92.
| 510(k) Owner’s Name | Grifols Diagnostic Solutions Inc. |
| --- | --- |
| Company Address | 10808 Willow Court. San Diego, CA 92127 |
| Phone Numbers | +1 (800) 452-6877 |
### Device
| Trade Name | Procleix® Plasmodium Quality Control |
| --- | --- |
| Common Name | N/A |
| Classification Name | Assayed Quality Control Material for Clinical Microbiology Assays |
| Regulation Number | 21CFR 866.3920 |
| Product Code | QTM |
| Establishment Registration | 3003460312 |
### Predicate Device
| Predicate Trade Name | Procleix® WNV/Babesia Quality Control |
| --- | --- |
| Predicate Common Name | N/A |
| Predicate Classification Name | Assayed Quality Control Material for Clinical Microbiology Assays |
| Regulation Number | 21CFR 866.3920 |
| Product Code | QTM |
| Predicate 510(k) Number | BK220746 |
### 1. Device Description
The single-use Procleix Plasmodium Quality Control is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from *Plasmodium falciparum* with the Procleix Plasmodium Assay performed on the Procleix Panther System. The Procleix Plasmodium Quality Control is designed to assist in monitoring of assay performance by providing an independent reference standard. Routine use of controls enables laboratories to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation and can assist in identifying increases in random or systematic errors. The Procleix Plasmodium Quality Control consists of one negative and one positive control. Each of the component is a filled individual vial with volume of 1.2 mL of material, packaged and sold separately.
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{1}
Grifols Diagnostic Solutions Inc.
10808 Willow Court.
San Diego, CA. 92127
USA
# GRIFOLS
## 2. Intended Use/Indications for Use
Procleix® Plasmodium Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from *Plasmodium falciparum* with the Procleix Plasmodium Assay. This product is intended to be used solely with the Procleix Plasmodium Assay, a licensed donor screening assay performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device.
## 3. Comparison with Predicate Device
Grifols Diagnostic Solutions is claiming Procleix WNV/Babesia Quality Control (BK220746) as the predicate. The tables below compare the similarities and differences between the subject and predicate devices.
**Table 1. General Device Characteristic Similarities**
| | Subject Device: Procleix® Plasmodium Quality Control | Predicate Device: BK220746 Procleix® WNV/Babesia Quality Control |
| --- | --- | --- |
| **Intended Use** | Procleix® Plasmodium Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from *Plasmodium falciparum* with the Procleix Plasmodium Assay. This product is intended to be used solely with the Procleix Plasmodium Assay, a licensed donor screening assay, performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device. | Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from *Babesia microti* and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System. This product is intended to be used solely with the Procleix Babesia Assay or Procleix WNV Assay, licensed donor screening assays performed on the Procleix Panther System. This product is not intended to replace manufacturer controls provided with the device. |
| **Test System** | Procleix Panther System | Same |
| **Storage (unopened)** | 24 months at -15° to -35°C Single-use only; discard after use. | Same |
| **Directions for Use** | Process as a sample | Same |
Page 2 of 5
{2}
Grifols Diagnostic Solutions Inc.
10808 Willow Court.
San Diego, CA. 92127
USA
# GRIFOLS
| | **Subject Device:** Procleix® Plasmodium Quality Control | **Predicate Device: BK220746** Procleix® WNV/Babesia Quality Control |
| --- | --- | --- |
| **Assay Steps Monitored** | Reverse transcription, amplification, detection | Same |
**Table 2. General Device Characteristic Differences**
| | **Subject Device:** Procleix® Plasmodium Quality Control | **Predicate Device: BK220746** Procleix® WNV/Babesia Quality Control |
| --- | --- | --- |
| **Physical Format** | Colorless liquid 2 vials, 1.2 mL each: • 1 vial of positive control • 1 vial of negative control | Colorless liquid 3 vials, 1.0 mL each: • 2 vials of positive control • 1 vial of negative control |
| **Composition** | • Procleix Plasmodium Positive Quality Control: A HEPES buffered solution containing detergent and RNA transcript • Procleix Plasmodium Negative Quality Control: A HEPES buffered solution containing detergent | • Procleix WNV Positive Quality Control: A HEPES buffered solution containing detergent and a WNV RNA transcript • Procleix Babesia Positive Quality Control: A HEPES buffered solution containing detergent and a Babesia RNA transcript • Procleix WNV/Babesia Negative Quality Control: A HEPES buffered solution containing detergent |
| **Number of Targets Monitored** | One | Multiple |
| **Assay Target Analyte** | *Plasmodium falciparum* | *Babesia* species (*B. microti*, *B. duncani*, *B. divergens*, and *B. venatorum*) and West Nile Virus |
| **Licensed Donor Screening Assays** | Procleix Plasmodium Assay | Procleix Babesia Assay and Procleix WNV Assay |
## 4. NON-CLINICAL PERFORMANCE EVALUATION
A summary of nonclinical performance testing associated with the Procleix Plasmodium Quality Controls is as follows:
### 4.1. Reproducibility
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{3}
Grifols Diagnostic Solutions Inc.
10808 Willow Court.
San Diego, CA. 92127
USA
# GRIFOLS
Two studies were performed to evaluate the reproducibility of the Procleix Plasmodium Positive and Negative Quality Controls (PQCs). The first reproducibility study was a multisite study using two independent reagent lots of the Procleix Plasmodium Assay with two unique lots of the PQCs. Testing was conducted by two operators each at three sites using three replicates for twelve days for a total of 216 tests for each PQC. The data obtained were analyzed for the components of Signal to cutoff (S/CO) variation between-run, within-run, between-days, between-instruments, and between operators. The second reproducibility study was a single site study to demonstrate the lot-to-lot reproducibility of the Positive and Negative PQCs. This study was performed using three additional independent reagent lots of the Procleix Plasmodium Assay with three unique lots of the PQCs. Testing was conducted by two operators using three replicates for six days for a total of 108 tests for each PQC. As shown in Tables 3 and 4, the results demonstrated a low variability in S/CO for the Plasmodium Positive Control, as evidenced by a % coefficient of variation (CV) of less than 10%. For the Plasmodium Negative Control, the S/CO values were < 0.02, the %CV values observed appear artificially high due to the low analyte S/CO values observed.
**Table 3. Reproducibility of Procleix Plasmodium Quality Controls tested with Procleix Plasmodium Assay**
| Panel | Mean S/CO | Between-Run SD | Between-Run %CV | Within Run SD | Within Run %CV | Between-Days SD | Between-Days %CV | Between-Instruments SD | Between-Instruments %CV | Between-Operators SD | Between-Operators %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Plasmodium Negative Control | 0.02 | 0.01 | 30.57 | 0.02 | 112.48 | 0.00 | 0.00 | 0.03 | 168.16 | 0.00 | 0.00 | 0.03 | 204.61 |
| Plasmodium Positive Control | 12.27 | 0.00 | 0.00 | 0.42 | 3.39 | 0.00 | 0.00 | 0.38 | 3.06 | 0.00 | 0.00 | 0.56 | 4.57 |
S/CO = Signal to cutoff; SD = Standard Deviation (SD reported as 0 due to rounding of a low non-zero value); CV = Coefficient of variation
**Table 4. Lot-to-Lot reproducibility of Procleix Plasmodium Quality Controls tested with Procleix Plasmodium Assay on the Procleix Panther Instrument**
| Panel | Mean S/CO | Within Run SD | Within Run %CV | Between-Days SD | Between-Days %CV | Between-Operators SD | Between-Operators %CV | Between-Lots SD | Between-Lots %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Plasmodium Negative Control | 0.00 | 0.01 | 537.47 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 537.47 |
| Plasmodium Positive Control | 12.46 | 0.39 | 3.16 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.39 | 3.16 |
S/CO = Signal to cutoff; SD = Standard Deviation (SD reported as 0 due to rounding of a low non-zero value); CV = Coefficient of variation
Page 4 of 5
{4}
Grifols Diagnostic Solutions Inc.
10808 Willow Court.
San Diego, CA. 92127
USA
# GRIFOLS
## 5.0 Conclusion
The Procleix Plasmodium Quality Control are *in vitro* transcript-based quality control reagents used to monitor the performance of *in vitro* nucleic acid procedures for the qualitative detection of RNA from *Plasmodium falciparum* with the Procleix Plasmodium Assay. It is comprised of single use vials that have an expiration date of 24 months when stored at -15°C to -35°C. The new Procleix Plasmodium Quality Control has the same technology, similar intended use, and the data presented demonstrates that the device is as safe, as effective, and performs as well as the predicate device.
Page 5 of 5
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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
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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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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.
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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.
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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.
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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.
