(32 days)
Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems.
The Elecsys® PreciControl Universal is a lyophilized product consisting of added antigens in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided document describes a 510(k) premarket notification for a medical device called "Elecsys® PreciControl Universal," a quality control material for immunoassays. The primary objective is to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, precision, or sensitivity. Instead, the "study" evaluates value assignment and performance characteristics stability, and the overall acceptance is based on demonstrating substantial equivalence to the predicate device.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Value Assignment | Must be comparable to the predicate device's performance for quality control. | "The Elecsys® PreciControl Universal was evaluated for value assignment..." (No specific quantitative results reported in this summary). |
| Stability | Must meet or exceed the stability characteristics of the predicate device. | "The Elecsys® PreciControl Universal was evaluated for... Performance Characteristics stability." (No specific quantitative results reported in this summary, but detailed stability claims are made, e.g., "Reconstituted (except for Insulin): on the analyzers at 20-25°C: up to 5 hrs"). |
| Intended Use | Must align with the intended use of the quality control for Elecsys® immunoassays. | "Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on Elecsys® immunoassay systems." This aligns with the predicate device's general use. |
| Levels | Must have the same number of levels as the predicate device. | "Two" (Same as predicate device). |
| Format | Must be the same format as the predicate device. | "Lyophilized" (Same as predicate device). |
| Handling | Handling procedures should be well-defined and practically usable. | Reconstitution with 3.0 mL distilled water, stand for 30 min. (Differs from predicate device's 2.0 mL and 15 min). This difference in handling implies a re-evaluation of performance based on these new conditions, though specific comparative results are not provided. |
| Matrix | Must be suitable for the intended quality control purpose. | "Human serum matrix with added Antigens" (Differs from predicate's "Equine serum with added C-Peptide and insulin"). The active ingredients are spiked into a buffered human serum matrix. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set. It mentions "The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability," but provides no details on how many runs, samples, or data points were used for these evaluations.
The data provenance (country of origin, retrospective/prospective) is also not mentioned within this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a quality control material, not a diagnostic device that interprets clinical images or data requiring expert consensus for ground truth. Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists) is not applicable here. The "ground truth" for a quality control material would typically be its assigned target values and demonstrated performance characteristics (e.g., stability). These values are established through rigorous laboratory testing and statistical analysis following established standards for assay development and quality control manufacturing, rather than expert interpretation of individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is a quality control material and not a device requiring human interpretation of results against a clinical ground truth, no adjudication method (like 2+1 on clinical cases) is mentioned or relevant. The "adjudication" would be in the form of laboratory quality control procedures and statistical analysis to ensure the product meets its specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are typically used for diagnostic imaging or similar devices where multiple human readers interpret cases, often with and without AI assistance, to measure the impact of the AI. This device is a quality control material for automated immunoassay systems; it does not involve human readers for interpretation, nor does it incorporate AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance. While the Elecsys® PreciControl Universal is used with automated Elecsys® immunoassay systems, the device itself is a reagent (quality control material), not an algorithm. Its performance is evaluated through its physical and chemical properties and how it performs on those automated systems. The concept of "standalone algorithm performance" as typically applied to AI or diagnostic software does not directly apply here. The document describes the evaluation of the control's properties and its suitability for quality control on the specified analyzers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control material like Elecsys® PreciControl Universal would typically be:
- Assigned Target Values: These are the expected concentrations or activity levels of the analytes within the control material, established through a robust process of multiple measurements using a reference method or a well-characterized set of instruments, often with multiple lots and replicates.
- Established Performance Specifications: These include data on its stability (shelf life, open-vial stability, freeze-thaw stability, on-board stability), homogeneity, and commutability (though commutability is not explicitly discussed here for these specific analytes, it's a general concept for QC materials).
The document states, "The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability." This implies that data was gathered to determine its assigned values and to confirm its stability profile.
8. The sample size for the training set
The concept of a "training set" is typically associated with machine learning or AI models. This device is a chemical reagent (quality control material). Therefore, there is no "training set" in the context of AI. The development process would involve extensive formulation, manufacturing, and testing to establish its characteristics, rather than training an algorithm.
9. How the ground truth for the training set was established
As there is no "training set" in the AI sense for this device, this question is not applicable. The "ground truth" (assigned values and performance characteristics) for the quality control material itself is established through analytical testing and characterization during the manufacturing and validation process.
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K 051687
JUL 25 2005
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 317-521-3723 |
| Contact Person: Corina Harper | |
| Date Prepared: June 22 , 2005 | |
| Device Name | Proprietary name: Elecsys® PreciControl Universal Common name: PreciControl Universal |
| Classification name: Multi-Analyte Controls, All Kinds (assayed and unassayed) | |
| Predicate Device | The Elecsys® PreciControl Universal is substantially equivalent to the currently marketed Elecsys® PreciControl MultiAnalyte (K033937). |
| Device Description | The Elecsys® PreciControl Universal is a lyophilized product consisting of added antigens in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on Elecsys® immunoassay systems. |
| Continued on next page |
.
510(k) Summary
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510(k) Summary, Continued
| Comparison toPredicateDevice | The Elecsys® PreciControl Universal is substantially equivalent to thecurrently marketed Elecsys® PreciControl MultiAnalyte (K033937). Thetable below compares Elecsys® PreciControl Universal with the predicatedevice, Elecsys® PreciControl MultiAnalyte (K033937). |
|---|---|
| -------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Similarities
| Characteristics | Elecsys® PreciControlUniversal | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) |
|---|---|---|
| Intended Use | Elecsys® PreciControlUniversal is used forquality control of theElecsys® immunoassayson the Elecsys®immunoassay systems. | Elecsys® PreciControlMultiAnalyte is used forquality control of theElecsys® C-Peptide andElecsys® Insulinimmunoassays on theElecsys® immunoassaysystems. |
| Levels | Two | Same |
| Format | Lyophilized | Same |
Continued on next page
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510(k) Summary, Continued
| Characteristics | Elecsys® PreciControlUniversal | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) |
|---|---|---|
| Handling | Reconstitute with exactly3.0 mL of distilled waterand allow to stand closedfor 30 minutes toreconstitute, and then mixgently. | Reconstitute with exactly2.0 mL of distilled waterand allow to stand closedfor 15 minutes toreconstitute, and then mixgently. |
| Stability | Unopened:• Store at 2-8°C untilexpiration dateReconstituted (except forInsulin):• on the analyzers at 20-25°C: up to 5 hrs• 20 - 25°C: up to 8 hrs• at 2-8°C: 3 days• at -20°C: 1 month (freezeonly once)Reconstituted of Insulin:• on the analyzers at 20-25°C: up to 5 hrs• 20 - 25°C: up to 5 hrs• at -20°C: 1 month (freezeonly once) | Unopened:• SameReconstituted:• on the analyzers at 20-25°C: up to 3 hrs• at -20°C: 1 month (freezeonly once)• after thawing: use onlyonce |
... ..........................................................................................................................................................................
Comparison to Predicate Device (continued) - Similarities
Differences
| Characteristics | Elecsys® PreciControlUniversal | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) |
|---|---|---|
| Matrix | Human serum matrix withadded Antigens (see Table1: "Matrix Composition") | Equine serum with addedC-Peptide and insulin |
Continued on next page
Roche Diagnostics Confidential
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510(k) Summary, Continued
The table below lists all active ingredients for Elecsys® PreciControl Matrix Composition Universal.
The active ingredients are spiked into a buffered human serum matrix
| Component | Concentration | |
|---|---|---|
| Reactive Components | AFP (human, cell culture) | please refer to target valuesheet of package insert |
| Cortisol (synthetic) | ||
| DHEAS (synthetic) | ||
| Estradiol (synthetic) | ||
| Ferritin (human) | ||
| Folate (synthetic) | ||
| FSH (human) | ||
| L-Thyroxin (synthetic) | ||
| hCG (human) | ||
| IgE (human) | ||
| Insulin (human, recomb.) | ||
| LH (human) | ||
| Progesterone (vegetable) | ||
| Prolactin (human) | ||
| Testosterone (vegetable) | ||
| SHBG (human) | ||
| T3 (synthetic) | ||
| TSH (human, recomb.) | ||
| Vitamin B12 (synthetic) |
Table 1
The Elecsys® PreciControl Universal was evaluated for value assignment and Performance Characteristics stability.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 25 2005
Ms. Corina Harper, RAC Regulatory Consultant Roche Diagnostics Corporation ... ... 9115 Hague Road Indianapolis, IN 46250
K051687 Re:
Trade/Device Name: Elecsys® PreciControl Universal Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 22, 2005 Received: June 24, 2005
Dear Ms. Harper:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because a substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the Medical Device the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Oosmetore, market the device, subject to the general controls provisions of the Act. The r ournal controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceling your av revealerse of your device to a legally premarked notification. "The I DA miding of bassance of the and thus, permits your device to proceed to the market. ..
If you desire specific information about the application of labeling requirements to your device, If you desire specific imorination acour tis appears device, please contact the Office of In
or questions on the promotion and advertising of your device the contact of the or questions on the promotion and advertising or your can be and Safety at (240) 276-0484. V Ito Diagnosite Device Devilance and barrey ... (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may outlier general miormations on your of the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
1
$\frac{1}{2} \times 10^{-12}$
510(k) Number (if known):
Device Name:
Elecsys® PreciControl Universal
Indications For Use:
Elecsys® PreciControl Universal is used for quality control of the Elecsys® immunoassays on the Elecsys® immunoassay systems.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| (Division Sign-Off) |
Division of Clinical Laboratory Devices 510(k) Number KOS 168
Roche Diagnostics Contidential
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.