← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K994291 # DIMENSION SPECIAL PROTEIN CALIBRATOR (K994291) _Dade Behring, Inc. · JIT · Mar 1, 2000 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K994291 ## Device Facts - **Applicant:** Dade Behring, Inc. - **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md) - **Decision Date:** Mar 1, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1150 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The Special Protein Calibrator is intended to be used to calibrate the complement component, C3 (C3), complement component,C4 (C4), Transferrin (TRNF), Immunoglobulin G (IGG), Immunoglobulin A (IGA), and Immunoglobulin M (IGM) methods on the Dimension® clinical chemistry system. ## Device Story Dimension® Special Protein Calibrator is a liquid human serum-based product; supplied as a kit of ten vials across five levels. Used to calibrate specific protein assays (C3, C4, Transferrin, IgG, IgA, IgM) on the Dimension® clinical chemistry system. Provides reference points for quantitative analysis of patient serum samples. Used by laboratory technicians in clinical chemistry environments. Output is a calibration curve used by the instrument to calculate analyte concentrations in patient samples, facilitating clinical diagnosis and monitoring of protein-related conditions. ## Clinical Evidence No clinical data; bench testing only. The device is a calibrator; substantial equivalence is established through comparison of intended use, matrix, and reference to standardized materials (IFCC, CRM 470). ## Technological Characteristics Liquid human serum-based calibrator; 5 levels; 1.5 mL per vial. Standardized to IFCC, CRM 470. Used for calibration of clinical chemistry assays. ## Regulatory Identification A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.) ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Predicate Devices - Beckman CAL 1 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K994291 # MAR - 1 2000 # DADE BEHRING DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714 ### Summary of Safety and Effectiveness Information This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR\$807.92. | Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date of Preparation: | December 20, 1999 | | Name of Product: | Dimension® Special Protein Calibrator | | FDA Classification Name: | Calibrator | | Predicate Device: | Beckman CAL 1 | | Device Description: | The Dimension® Special Protein Calibrator is a liquid human serum-
based product supplied as a kit of ten vials; two at each of five levels. | | Intended Use: | The Special Protein Calibrator is intended to be used to calibrate the
complement component, C3 (C3), complement component,C4 (C4),
Transferrin (TRNF), Immunoglobulin G (IGG), Immunoglobulin A
(IGA), and Immunoglobulin M (IGM) methods on the Dimension®
clinical chemistry system. | #### Comparison to Predicate Device: | | | Dimension® | |------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | Device | Beckman CAL 1 | Special Protein Calibrator | | Intended Use: | Calibrator | Calibrator | | Analytes: | Complement C3 (C3)
Complement C4 (C4)
Transferrin (TRF)
Immunoglobulin G (IgG)
Immunoglobulin A (IgA)
Immunoglobulin M (IgM)
Alpha₁ -acid glycoprotein (AAG)
Haptoglobin (HPT)
Kappa light chain (KAP)
Lambda light chain (CAM) | Complement C3 (C3)
Complement C4 (C4)
Transferrin (TRNF)
Immunoglobulin G (IGG)
Immunoglobulin A (IGA)
Immunoglobulin M (IGM) | | Matrix:
Form:
Volume:
Levels:
Reference: | Human serum base
Liquid
3.0 mL per vial, reconstituted
1 level
IFCC, CRM 470 | Human serum base
Liquid
1.5 mL per vial
5 levels
IFCC, CRM 470 | {1}------------------------------------------------ #### Comments on Substantial Equivalence: Both the Beckman CAL 1 and the Dimension® Special Protein Calibrator are intended as calibrators for C3, C4, Transferrin, IgG, IgA, and IgM methods. #### Conclusion: The Dimension® Special Protein Calibrator is substantially equivalent to the Beckman CAL 1 calibrator based on the comparison discussed above. K.M. Knight Richard M. Vaught Regulatory Affairs and Compliance Manager Date: December 20, 1999 {2}------------------------------------------------ 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 with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. ## MAR = 1 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Re: K994291 Trade Name: Dimension® Special Protein Calibrator Regulatory Class: II Product Code: JIT Dated: December 20, 1999 Received: December 21, 1999 Dear Mr. Vaught: 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. {3}------------------------------------------------ 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 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 {4}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT Device Name: Dimension® Special Protein Calibrator #### Indications for Use: The Special Protein Calibrator for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to establish points of reference that are used in determination of human IgA, IgG, IgM, complement C3, complement C4, and Transferrin values. Richard M. Vaught Regulatory Affairs and Compliance Manager 在新闻网易是民营商品名誉的地址:老宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝宝 February 17, 2000 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Peter E. Mahison (Division Sign-Division of Clinical Laboratory Dev 510(k) Numbe Prescription Use (Per 21 CFR 801.109) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ OR Over-the-counter Use_ (Optional format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K994291](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K994291) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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