(18 days)
Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
Para Tech Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
The provided text describes a 510(k) summary for a medical device called "Para Tech Plus Retics," an assayed hematology control. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo acceptance criteria with supporting studies as typically seen for novel devices.
Therefore, the information regarding specific acceptance criteria and detailed study results to prove device performance against those criteria is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating that the new device is "substantially equivalent" to an existing one.
However, I can extract the information provided about the overall study and conclusions:
1. Table of Acceptance Criteria and Reported Device Performance:
As mentioned, explicit, quantified acceptance criteria (e.g., specific thresholds for a given metric) are not provided in this 510(k) summary. The "reported device performance" is described qualitatively as meeting the overall goals of the studies.
| Acceptance Criteria (Not explicitly stated in quantitative terms; inferred from study goals) | Reported Device Performance (Qualitative) |
|---|---|
| Run to Run Reproducibility | Consistently reproducible |
| Substantial equivalence to predicate product (Para Tech) | Substantially equivalent to the predicate product |
| Long-Term Stability | Stable for the entire product dating |
| Open Vial Stability | Stable for the entire product dating |
| Effectiveness for controlling CBC/Diff/Retic parameters | Safe and effective for controlling CBC/Diff/Retic parameters (when used as instructed) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Four studies of Para Tech Plus Retics were conducted: I) Run to Run Reproducibility and Comparison to Whole Blood; II) Site to Site Reproducibility; III) Long Term Stability; and IV) Open Vial Stability." However, no specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these studies are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable/Not provided. This is an in-vitro diagnostic control device, not an imaging or diagnostic algorithm that relies on expert interpretation of results to establish ground truth. Its "ground truth" would likely be laboratory measurements and comparisons to established reference methods or predicate devices.
4. Adjudication Method for the Test Set:
Not applicable/Not provided. As stated above, this is an in-vitro diagnostic control. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results, not for the performance validation of a hematology control.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or analytical devices where human interpretation plays a role. This device is a control for automated hematology instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable (in the typical sense of an AI algorithm). The "device" is a physical control substance. The performance being evaluated is its interaction with and control over automated hematology analyzers, not an algorithm's standalone output. The studies aimed to prove the control's reproducible and stable performance on these instruments.
7. The Type of Ground Truth Used:
The ground truth for proving the device's performance is implicitly based on:
- Comparison to Whole Blood: For the "Run to Run Reproducibility and Comparison to Whole Blood" study.
- Comparison to Predicate Device (Para Tech): For establishing "substantial equivalence."
- Laboratory measurements and established methods: To assess reproducibility and stability over time.
8. The Sample Size for the Training Set:
Not applicable/Not provided. This device is a control, not an AI/ML algorithm that requires a training set. Its formulation would have been developed through R&D, but not in the sense of an algorithm's training data.
9. How the Ground Truth for the Training Set was Established:
Not applicable/Not provided. (See point 8).
{0}------------------------------------------------
NOV 300 1999
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories, Inc.P.O. Box 45625Omaha, NE 68145-0625 |
|---|---|
| Official Correspondent: | Paul KittelsonQuality Assurance/Regulatory Affairs(402) 691-7465 |
| Date Prepared: | November 8, 1999 |
| Names of Device: | |
| Trade Name: | Para Tech Plus Retics |
| Common Name: | Assayed hematology control |
| Classification Name: | White and red cell (and reticulocyte) control (§ 864.8625) |
| Predicate Device: | Para Tech (K896154) manufactured by StreckLaboratories |
- Description: Para Tech Plus Retics is a suspension of stabilized human red blood cells, human white cells, simulated human platelets, and simulated human reticulocytes packaged in glass vials containing 4.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
- Intended Use: Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
- Comparison with Predicate Device: Like Para Tech, Para Tech Plus Retics is intended for CBC/WBC differential performance validation of Bayer Advia 120 and Technicon H-Series hematology instruments. Both devices contain stabilized human red blood cells, human white cells, and simulated platelets which properly mimic human whole blood components on Baver Advia 120 analyzers.
Unlike Para Tech, Para Tech Plus Retics contains a stabilized human reticulocyte component. This allows the Advia user to control CBC, WBC differential, and on-line reticulocyte analysis simultaneously with a single device.
- Discussion of Tests and Test Results: Four studies of Para Tech Plus Retics were conducted: I) Run to Run Reproducibility and Comparison to Whole Blood; II) Site to Site Reproducibility; III) Long Term Stability; and IV) Open Vial Stability. Study results showed Para Tech Plus Retics to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.
- Conclusions Drawn From Tests: Para Tech Plus Retics is safe and effective for controlling CBC/Diff/Retic parameters on Bayer Advia 120 and Technicon H-Series instruments when used as instructed in the product package insert.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 30 1999
Mr. Paul Kittelson Ouality Assurance/Regulatory Affairs Streck Laboratories, Inc. 14124 Industrial Road Omaha, Nebraska 68144
Re: K993825 Trade Name: Para Tech Plus Retics Regulatory Class: II Product Code: JCN Dated: November 8, 1999 Received: November 12, 1999
Dear Mr. Kittelson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
{3}------------------------------------------------
K 993825
Not Assigned 510(k) Number (if known): __
Para Tech Plus Retics Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use: Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Set E. Maker
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices 14993875
510(k) Number
Prescription Use_V (Per 21CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
October 6, 1999 ---Date __
§ 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.