(56 days)
STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated, semi-automated and manual procedures that measure blood cell parameters.
STaK-Chex Plus Retics is a stabilized suspension of human red blood cells, a nucleated red blood cell analog, a white blood cell component consisting of human analogs and a platelet component consisting of a non-human analog in a preservative medium. The product is packaged in plastic vials containing 5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
The provided document describes the 510(k) submission for STaK-Chex® Plus Retics, an assayed hematology control. It details the device, its intended use, comparison to a predicate device, and the general types of studies conducted. However, it does not provide detailed acceptance criteria or the specific quantitative results of a study designed to prove the device meets those criteria in a format applicable to evaluating a medical diagnostic AI device.
This submission is for a quality control product, not an AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. The studies cited are focused on product stability and reproducibility to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested points cannot be answered based on the provided text, as they pertain to a different type of device evaluation (e.g., AI diagnostic device performance).
Here's an attempt to extract relevant information and note what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for parameters like accuracy, precision, sensitivity, or specificity. The evaluation is focused on demonstrating "substantial equivalence" to a predicate device and stability. The "reported device performance" is qualitative, indicating consistent reproducibility and stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Consistent Reproducibility (against predicate and itself) | "Consistently reproducible" |
| Substantial Equivalence to predicate device (STaK-Chex Plus Retics (K992887)) | "Substantially equivalent to the predicate product" |
| Stability for claimed shelf life | "Stable for the shelf life claimed" and "stable for the entire product dating" |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The studies mentioned are: Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and External Site recovery of values. The number of samples (vials, runs, sites) used for each of these tests is not quantified.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal (from Streck) and possibly external (for recovery of values), but no specific locations are provided.
- Retrospective or Prospective: Not specified. Stability studies are typically prospective over time, but the overall nature of the data collection isn't detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this device type. The "ground truth" for a quality control product like STaK-Chex Plus Retics would be the expected values of the blood cell parameters it is designed to measure, established through manufacturing processes and validated assays, rather than expert interpretation of images or patient data. No experts are mentioned in the context of establishing ground truth for the test set.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for disputes in expert interpretation of diagnostic results, which is not relevant for a quality control product.
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
Not applicable. This device is a hematology quality control mixture, not an AI or diagnostic system that human readers would use or that would assist human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this product type is its assigned values for blood cell parameters, which are established during manufacturing and validated through internal testing and calibration with reference methods. The document states it is an "assayed whole blood control," meaning its values are predetermined. The studies confirm that new lots or conditions (stability) maintain these expected values.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device.
In summary, the provided 510(k) summary focuses on demonstrating that a new version of a quality control product is substantially equivalent to an existing one by proving its stability and reproducibility. The type of acceptance criteria and study details requested are typically for diagnostic AI systems, which do not apply to this product.
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Ko90137
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck7002 South 109th StreetOmaha, NE 68128 | MAR 1 8 2009 |
|---|---|---|
| Official Correspondent: Carol Thompson, Quality Assurance Manager(402)-537-5213 | ||
| Date Prepared: | January 19, 2009 | |
| Name of Device:Trade Name:Common Name:Classification Name: | STaK-Chex® Plus ReticsAssayed Hematology ControlHematology quality control mixture (864.8625) | |
| Predicate Device: | STaK-Chex Plus Retics (K992887) Manufactured by Streck |
Description:
STaK-Chex Plus Retics is a stabilized suspension of human red blood cells, a nucleated red blood cell analog, a white blood cell component consisting of human analogs and a platelet component consisting of a non-human analog in a preservative medium. The product is packaged in plastic vials containing 5ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels (low, normal and high). The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10° C.
Intended Use:
STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated, semi-automated and manual procedures that measure blood cell parameters.
| STaK-Chex Plus Retics (Predicate Product) | STaK-Chex Plus Retics | |
|---|---|---|
| Intended UseStatement | STak-Chex Plus Retics is intendedto be used as a control for completeblood cell count (CBC), white cell 5-part differential, and reticulocyteparameters on Beckman CoulterGenS series hematologyinstruments. | STaK-Chex Plus Retics is anassayed whole blood control forevaluating the accuracy andprecision of automated, semi-automated and manual proceduresthat measure blood cellparameters. |
| Open Vial Stability | 14 days | Same |
| Closed Vial Stability | 105 days | 75 days |
| Reagents | Stabilized human and animal blood | Low Level - Stabilized human andanimal blood, plus a nucleated redblood cell analogNormal and High Levels same asPredicate |
| Storage Conditions | 2 - 10°C | Same |
Comparison to Predicate Device:
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Discussion of Tests and Test Results:
Four types of studies were conducted to establish performance of STaK-Chex Plus Retics. The four tests conducted were Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and External Site recovery of values. All testing showed that STaK-Chex Plus Retics is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.
Conclusions Drawn From Tests:
Study results show STak-Chex Plus Retics to be consistently reproducible, substantially equivalent to the products, and stable for the entire product dating. STaK-Chex Plus Retics 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 Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 2009
Streck, Inc. c/o Ms. Kerrie Oetter Quality Assurance Coordinator 7002 South 109th St. Omaha, Nebraska 68128
Re: K090137
Trade/Device Name: STaK-Chex ® Plus Retics. Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control mixture Regulatory Class: II Product Code: GLQ Dated: March 4, 2009 Received: March 10, 2009
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/trav. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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
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Page 2 - Ms. Kerrie Oetter
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, pennits your device to proceed to the market.
If you desire specific advice for your device on the labeling regulation, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240- 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For question regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. You many obtain other general information on your responsibilities under the Act from the Division of Small Manufactuers, 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,
ia m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name: STaK-Chex Plus Retics
Indication For Use:
STaK-Chex Plus Retics is an assayed whole blood control for evaluating the accuracy and precision of automated procedures that measure blood cell parameters.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Stephine Bautista
Division Sign-Off Office of In Vito Diagnostic Device Evaluation and Safety
510(k) K090137
§ 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.