(32 days)
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No
The device is a linearity control kit for hematology instruments, consisting of stabilized blood cells. The description focuses on the physical composition and stability studies, with no mention of AI or ML.
No
The device is described as an assayed linearity control kit used to assess instrument accuracy and verify patient reportable ranges, not to treat a medical condition or restore health.
No
This device is described as an "assayed linearity control kit" used to "assess the instrument's accuracy and to verify patient reportable ranges" of automated hematology instrumentation. It is a control to check the performance of a diagnostic instrument, not a diagnostic device itself.
No
The device description clearly states it is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is used to "assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes." This indicates it is used in the process of analyzing biological samples (blood) to provide information about a patient's health status (reticulocyte count).
- Device Description: The device is a "suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials." This is a reagent or control material used in laboratory testing.
- Function: It is used to verify the performance of automated hematology instruments, which are used for in vitro diagnostic testing.
Therefore, based on the provided information, Retic-Chex Linearity for BC fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Retic-Chex Linearity for BC is an assayed linearity control kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.
Product codes (comma separated list FDA assigned to the subject device)
JPK
Device Description
Retic-Chex Linearity for BC is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials, containing 3.0 mL volumes. The device consists of five levels of reticulocyte percentage range from 0 to 29.5%. Closures are injection molded polypropylene screw top caps. The vials are packaged in a welled vacuum formed clam-shell container with the package insert and assay sheet.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Three studies of Retic-Chex Linearity for BC were conducted: I) Run to Run Reproducibility and Comparison to Whole Blood; II) Long Term Stability; and III) Open Vial Stability. Study results showed Retic-Chex Linearity for BC to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Retic-Chex Linearity manufactured by Streck
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck
7002 South 109 th Street
Omaha, NE 68128 |
|-------------------------|------------------------------------------------------------------|
| Official Correspondent: | Carol Thompson
Quality Assurance Manager
(402) 537-5313 |
| Date Prepared: | January 19, 2007 |
| | FEB 2 3 2007 |
| Names of Device: | |
| Trade Name: | Retic-Chex ® Linearity for BC |
| Common Name: | Hematology Linearity Material |
| Classification Name: | Hematology quality control mixture (§ 864.8625) |
Predicate Devices:
Retic-Chex Linearity manufactured by Streck
Description:
Retic-Chex Linearity for BC is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials, containing 3.0 mL volumes. The device consists of five levels of reticulocyte percentage range from 0 to 29.5%. Closures are injection molded polypropylene screw top caps. The vials are packaged in a welled vacuum formed clam-shell container with the package insert and assay sheet.
Intended Use:
Retic-Chex Linearity for BC is an assayed linearity control kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.
Comparison with Predicate Devices:
| | Predicate - Retic-Chex Linearity | Product - Retic-Chex Linearity for
BC |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Closed Vial
Stability | 105 days | 105 days |
| Open Vial Stability | 5 days | 5 days |
| Intended Use | Retic-Chex Linearity is a multi level
calibration (linearity) assessment kit for
reticulocyte counting. It is designed for
use on the following instruments: Bayer
Advia 120, Sysmex R-3000, Sysmex
XE-2100, and Abbott Cell-Dyn 4000.
Use of this kit allows users to satisfy
CAP requirements and CLIA
recommendations to verify patient
reportable ranges. | Retic-Chex Linearity for BC is an
assayed linearity control kit, which
can be used to assess the
instrument's accuracy and to verify
patient reportable ranges of
automated and semi-automated
hematology instrumentation capable
of enumerating reticulocytes. |
| Formulation | | Same formula as Retic-Chex
Linearity. The only difference is the
way the retics are processed. |
| Storage
Conditions | 2 - 10°C | 2 - 10°C |
| Level 1 range | 0.4% - 1.1% | 0.4% - 1.1% |
| Level 2 range | 4.4% - 5.6% | 4.7% - 6.8% |
| Level 3 range | 8.6% - 10.0% | 9.5% - 12.0% |
| Level 4 range | 12.7% - 14.4% | 14.2% - 17.2% |
| Level 5 range | 23% - 25% | 26.5% - 29.5% |
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Discussion of Tests and Test Results:
Three studies of Retic-Chex Linearity for BC were conducted:
I) Run to Run Reproducibility and Comparison to Whole Blood; II) Long Term Stability; and III) Open Vial Stability. Study results showed Retic-Chex Linearity for BC to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating.
Conclusions Drawn From Tests:
Study results show Retic-Chex Linearity for BC to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. Retic-Chex Linearity for BC is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.
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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 consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
STRECK
C/O Kerrie Oetter 7002 South 109th Street Omaha, Nebraska 68128
FEB 2 3 2007
Re: K070199
Trade/Device Name: Retic-Chex Linearity for BX Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK Dated: January 19, 2007 Received: January 22, 2007
Dear Ms. Oetter:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert M. Becker
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K070199 510(k) Number (if known):
Retic-Chex® Linearity for BC Device Name:
Indications For Use:
Retic-Chex Linearity for BC is an assayed linearity kit, which can be used to assess the instrument's accuracy and to verify patient reportable ranges of automated hematology instrumentation capable of enumerating reticulocytes.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
Josephine Bautista
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety