(13 days)
Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity. For In Vitro Diagnostic Use
Medica EasyQC Hematocrit Control is a specially formulated, two-level, aqueous liquid material intended to monitor hematocrit measurement by the Medica EasyStat analyzer. Medica EasyQC Hematocrit Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. Medica EasyQC Hematocrit Control is an electrolyte solution with conductivity at two levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the Medica EasyStat Analyzer. Medica EasyQC Hematocrit Control is a non-hazardous aqueous solution containing no biological materials.
The provided document for the Medica EasyQC Hematocrit Control is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving performance against those criteria. As such, much of the requested information (like specific acceptance criteria, sample sizes, ground truth methodologies derived from expert consensus or pathology, MRMC studies, or detailed standalone performance) is not present in the provided text.
The document states that "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of products with the same formulation and failure mode to support stability. b) Test precision", but it does not elaborate on the specific acceptance criteria for these tests nor the results in a quantitative manner.
Based on the provided information, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state quantitative acceptance criteria or detailed-performance results for the Medica EasyQC Hematocrit Control itself beyond its characteristics. The comparison table below highlights characteristics used to establish substantial equivalence, not performance against specific criteria.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Characteristics compared to predicate) |
|---|---|
| Functional Equivalence: | |
| - Number of levels | 2 (Matches Predicate: RNA QC900) |
| - Analytes | Hematocrit (Matches Predicate: RNA QC900) |
| - Container | Clear, glass ampoule (Matches Predicate: RNA QC900) |
| - Fill volume | 1.7 mL (Matches Predicate: RNA QC900) |
| - Color | Clear (Matches Predicate: RNA QC900) |
| - Matrix | Buffered, aqueous electrolyte solution (Matches Predicate: RNA QC900) |
| Intended Use Equivalence: | To monitor and evaluate the analytical performance of the Medica EasyStat analyzer for hematocrit measurement by conductivity. (Matches Predicate) |
| Technological Characteristics Equivalence: | Aqueous electrolyte solutions with conductivity to simulate clinically relevant hematocrit concentrations. (Matches Predicate) |
| Performance Tests Conducted: | |
| - Stability | Real-time evaluation of products with the same formulation and failure mode was performed to support stability. (No quantitative results reported.) |
| - Precision | Test precision was performed. (No quantitative results reported.) |
Detailed Study Information (Based on availability in the document)
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "Tests were conducted" for stability and precision but does not provide details on the number of samples or measurements in these tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The device is a quality control material, not a diagnostic device that requires ground truth established by medical experts in the same way an AI diagnostic algorithm would.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided. As a quality control material and not a diagnostic tool requiring interpretation, this type of adjudication would not be relevant.
-
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:
- No. This device is a hematocrit control material, not an AI-assisted diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant and were not performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This concept is not applicable to a hematocrit control solution.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a control material, the "ground truth" would typically refer to the known, assigned value of the control material (e.g., its target hematocrit concentration). The document does not specify how these target values were established or verified, beyond stating it's an "electrolyte solution with conductivity at two levels appropriate to simulate clinically relevant hematocrit concentrations."
-
The sample size for the training set:
- This information is not applicable/provided. This device is a manufactured chemical control solution, not a machine learning algorithm that requires a training set.
-
How the ground truth for the training set was established:
- This information is not applicable/provided for the reasons mentioned above.
Summary of the Study:
The provided document describes a 510(k) premarket notification for the "Medica EasyQC Hematocrit Control." The "study" presented is primarily a comparison of the new device's technological characteristics, formulation, and intended use against legally marketed predicate devices (specifically, RNA QC900 Hematocrit Control, K955630) to establish substantial equivalence.
The document states that "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of products with the same formulation and failure mode to support stability. b) Test precision." However, no quantitative data, methods, or results of these tests are provided in this summary. The conclusion drawn is that the "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."
This 510(k) summary focuses on demonstrating that the new control device is as safe and effective as existing legally marketed devices, rather than establishing its performance against a detailed set of quantitative acceptance criteria through extensive clinical trials or complex AI model validation studies.
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KC021924
BIONOSTICS
ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1972 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ، ﻭﻳﺘﺤﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ ﮐﺮ ﮐﺮ ﮨﮯ۔
JUN 2 4 2002
510(k) Summary*
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 772-7070 x 220
Date of preparation of this summary: 7 June 2002
- Device trade or proprietary name: (2) Medica EasyQC Hematocrit Control
Device common or usual name or classification name:
Control, Hematocrit
| PRODUCT NOMENCLATURE | CLASSIFICATION | |
|---|---|---|
| NUMBER | CLASS PANEL | |
| HEMATOCRIT CONTROL | 864.8625 | GLK II HEMATOLOGY |
(3) Substantial Equivalence
Medica EasyQC Hematocrit Control is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:
Comparison of Medica EasyQC to predicate devices for substantial equivalency
| Characteristic | Predicate Devices | Modified Device |
|---|---|---|
| Name:510(k), Date: | RNA QC900 Hematocrit ControlK955630 | Medica EasyQC Hematocrit |
| Number of levels: | 2 | 2 |
| Analytes: | Hematocrit | Hematocrit |
| Container: | clear, glass ampoule | clear, glass ampoule |
| Fill volume: | 1.7 mL | 1.7 mL |
| Color: | clear | Clear |
| Matrix: | Buffered, aqueous electrolyte solution | Buffered, aqueous electrolyte solution |
* This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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(4) Description of the new device
Medica EasyQC Hematocrit Control is a specially formulated, two-level, aqueous liquid material intended to monitor hematocrit measurement by the Medica EasyStat analyzer. Medica EasyQC Hematocrit Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.
Medica EasyQC Hematocrit Control is an electrolyte solution with conductivity at two levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the Medica EasyStat Analyzer.
Medica EasyQC Hematocrit Control is a non-hazardous aqueous solution containing no biological materials.
(5) Intended use of the device
Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity.
(6) Technological characteristics of the device.
This material consists of buffered aqueous electrolyte solutions with conductivity to simulate clinically relevant concentrations hematocrit to span the range of values typical for such products with the same intended use.
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.
Tests were conducted to verify specific performance requirements:
- a) Real-time evaluation of products with the same formulation and failure mode to support stability.
- b) Test precision
(b) (2) Summary of clinical tests submitted with the premarket notification for the device.
N/A
(b) (3) Conclusions drawn from the clinical and non-clinical trials.
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen Storro Director, Quality Assurance and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, Massachusetts 01432
JUN 2 4 2002
Re: K021924
Trade/Device Name: Medica EasyQC Hematocrit Controls Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology QC Mixture Regulatory Class: II Product Code: GLK Dated: June 7, 2002 Received: June 11, 2002
Dear Ms. Storro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Medica EasyQC Hematocrit Controls Device Name:
Indications for Use:
Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity.
For In Vitro Diagnostic Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K021924 |
|---|---|
| --------------- | --------- |
510(K) MEDICA EASYQC HEMATOCRIT-REVISED
Over-The-Counter Use___
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§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.