← Product Code [QTM](/productcode/QTM) · BK251300 # Procleix Plasmodium Quality Control (BK251300) _Grifols Diagnostic Solutions Inc. San Diego, CA 92127 · QTM · Mar 26, 2026 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK251300 ## Device Facts - **Applicant:** Grifols Diagnostic Solutions Inc. San Diego, CA 92127 - **Product Code:** [QTM](/productcode/QTM.md) - **Decision Date:** Mar 26, 2026 - **Decision:** SESE - **Regulation:** 21 CFR 866.3920 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## 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). ## Regulatory 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.” ## Predicate Devices - Procleix® WNV/Babesia Quality Control ([BK220746](/device/BK220746.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. Page 1 of 5 {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 Page 3 of 5 {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 --- **Source:** [https://fda.innolitics.com/device/BK251300](https://fda.innolitics.com/device/BK251300) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com